Deep Penetrating Electro-magnetic Stimulator
`
`Deep Penetrating
`Electro-Magnetic Therapy
`
`LUMENIS EX1018
`Page 1
`
`

`

`Deep Penetrating Electro-magnetic Stimulator
`New choice, new satisfaction “Talent”
`
`Clinical Application
`- Disorders on backbone
`- Acute/chronic lumbago, Hip gout(sciatica), Spina bifida, Spondylitis
`
`Nerve disorders : Damage on a peripheral nerve
`
`Musculoskeletal disorders
`- Degenerative arthritis, Rheumatoid arthritis,
`- Cervical pain, Muscle relaxation, Frozen shoulder
`
`Genitourinary diseases : Prostate pain
`
`For pain control after car accident
`For rehabilitation purpose on nerve or muscle after the fracture
`For pain control from muscle atrophy, spasm, ankylosis
`For sport injuries
`
`*Multifunctional Stimulator “Talent” delivers superior results in any application.
`
`LUMENIS EX1018
`Page 2
`
`

`

`More Innovate
`Human body is a good conducting medium and also conductive to magnetic field. Once high-power pulsed
`magnetic field is transmitted momentarily, human tissues are stimulated as magnetic field penetrates, and
`this stimulates nerve cells, muscles, and blood vessels consecutively. Unlike general electric stimulation,
`stimulation generated by strong magnetic field affects deep inside the body because it penetrates, not just
`stimulates the surface.
`
`Through stimulation on the muscular tissue and nerve tissue, Salus-Talent treats pain control and stimulates
`blood vessel. Consequently, it can directly induce bloodstream.
`
`In addition to various demonstrated effects, stimulation by magnetic field is expected other physiological
`efficacy and clinical trials are under way on its demonstration globally.
`
`Expanded Capabilities
`
`Mechanism and Features
`
`High power
`supply
`(volt/Current)
`
`Stimulation
`Coil
`
`AC High power
`Electromagnetic
`Field
`
`Skin / Bone
`Penetration
`
`Target
`Therapy
`(Deep penetration)
`
`It generates strong magnetic field(applying eddy current deep inside)precise magnetic
`field that can pass through clothes, tissues and bones which enables stimulation
`of a particular area deep inside the body without surgery. It almost does not cause
`pain during treatment and patients can get treatment with great ease.
`
`LUMENIS EX1018
`Page 3
`
`

`

`Specification
`
`Magnetic Power
`
` 2Tesla±20%
`
`Magnetic Frequency
`
`Symmetric Biphasic Pulse, 1~50Hz
`
`Treatment Protocol
`
`4 User Mode, 4 Auto Mode
`
`Treatment Time
`
`1~60min.
`
`Interface
`
`6 Button, 1 Jog Shuttle
`
`Rated Voltage
`
`100~250Vac, 50/60Hz
`
`Company History
`
`2005
`
`2003 Corporate Establishment
`Releasing CR-3000 for the magnetic treatment of joint pains
`Permit of medical instrument manufacturing business(KFDA)
`2004 New product introduction/announcement of TAMAS for the magnetic evoked potential(Kangnam St.Mary’s Hospital)
`Establishment of corporate R&D center
`Selected as the managing company for the government project sponsored by the Ministry of Commerce, Industry & Energy
`Developing brain map diagnosis system(MEG) using biomagnetic field
`Selected as the managing company for the government project sponsored by the Ministry of Health & Welfare
`Developing X-ray detector with Photon Counting Method capabilities
`Certificate of Venture company(Small and Medium Business Administration)
`Acquisition of Certificate EN ISO9001-2000
`2007 Development of combined stimulator(Salus-Talent) for medical purpose
`Acquisition of permit for manufacture of laser irradiation instrument for medical purpose
`Patent application of TAMAS
`Patent application of Salus-Talent
`Acquisition of ISO13485
`TAMAS receiving Excellence Award from Technology Exhibition of Healthcare Industry
`President & CEO Geun Yong Lee receiving award from Commissioner of KFDA
`2008 Development of body age measurement system(developed collaboratively with SMT Germany)
`TAMAS certified for quality by Korea Health Industry Development Institute
`Acquisition of GH Mark
`Acquisition of INNO-BIZ
`Releasing Salus-Talent
`Acquisition of Salus-Talent CE certificate
` Acquisition of TAMAS CE certificate
`Patent for ESWT created using electromagnetic
`Acquisition of Salus-Talent III for ESWT/pain solution
`2010 Releasing ESWT Rosetta
`
`2009
`
`Seoul Branch
`
`4F, Changdae B/D, Sanjeon-dong 49-1, Baegjegobunro 224, Sonpa-gu, Seoul, Korea
`Tel: +82-1588-7395 Fax: +82-2-418-0986
`
`Factory
`/ R&D Center
`
`#301~303, Migun Techno World II, 187, Techno 2ro, Yuseong-gu, 305-500, Korea
`Tel : +82-42-934-5560~1 Fax : +82-42-934-5562
`
`LUMENIS EX1018
`Page 4
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`
`
`www.archive.org
`
`415.561.6767
`
`415.840-0391 e-fax
`
`
`
`Internet Archive
`
`300 Funston Avenue
`
`San Francisco, CA 94118
`
`_____________________
`
`
`
`AFFIDAVIT OF DUNCAN HALL
`
`
`
`1. I am a Records Request Processor at the Internet Archive, located in San Francisco,
`California. I make this declaration of my own personal knowledge.
`
`
`2. The Internet Archive is a website that provides access to a digital library of Internet
`sites and other cultural artifacts in digital form. Like a paper library, we provide
`free access to researchers, historians, scholars, and the general public. The Internet
`Archive has partnered with and receives support from various institutions,
`including the Library of Congress.
`
`
`3. The Internet Archive has created a service known as the Wayback Machine. The
`Wayback Machine makes it possible to browse more than 450 billion pages stored
`in the Internet Archive's web archive. Visitors to the Wayback Machine can search
`archives by URL (i.e., a website address). If archived records for a URL are
`available, the visitor will be presented with a display of available dates. The visitor
`may select one of those dates, and begin browsing an archived version of the Web.
`Links on archived files in the Wayback Machine point to other archived files
`(whether HTML pages or other file types), if any are found for the URL indicated
`by a given link. For instance, the Wayback Machine is designed such that when a
`visitor clicks on a hyperlink on an archived page that points to another URL, the
`visitor will be served the archived file found for the hyperlink’s URL with the
`closest available date to the initial file containing the hyperlink.
`
`
`4. The archived data made viewable and browseable by the Wayback Machine is
`obtained by use of web archiving software that automatically stores copies of files
`available via the Internet, each file preserved as it existed at a particular point in
`time.
`
`
`5. The Internet Archive assigns a URL on its site to the archived files in the format
`http://web.archive.org/web/[Year in yyyy][Month in mm][Day in dd][Time code in
`hh:mm:ss]/[Archived URL] aka an “extended URL”. Thus, the extended URL
`http://web.archive.org/web/19970126045828/http://www.archive.org/ would be the
`URL for the record of the Internet Archive home page HTML file
`(http://www.archive.org/) archived on January 26, 1997 at 4:58 a.m. and 28
`seconds (1997/01/26 at 04:58:28). The date indicated by an extended URL applies
`to a preserved instance of a file for a given URL, but not necessarily to any other
`files linked therein. Thus, in the case of a page constituted by a primary HTML file
`and other separate files (e.g., files with images, audio, multimedia, design
`elements, or other embedded content) linked within that primary HTML file, the
`primary HTML file and the other files will each have their own respective extended
`URLs and may not have been archived on the same dates.
`
`6. Attached hereto as Exhibit A are true and accurate copies of screenshots of the
`Internet Archive's records of the archived files for the URLs and the dates specified
`in the attached coversheet of each printout.
`
`LUMENIS EX1018
`Page 5
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`

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`
`
`7. Attached hereto as Exhibit B are true and accurate copies of the Internet Archive's
`records of the archived files for the URLs and the dates specified in the attached
`coversheet of each file.
`
`8. I declare under penalty of perjury that the foregoing is true and correct.
`
`
`
`
`DATE: ________________________
`
`
`________________________
`Duncan Hall
`
`
`
`
`
`
`
`09/28/2021
`
`LUMENIS EX1018
`Page 6
`
`

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`
`
`
`
`
`
`
`
`
`
`EXHIBIT A
`EXHIBIT A
`
`LUMENIS EX1018
`Page 7
`
`LUMENIS EX1018
`Page 7
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`

`

`https://web.archive.org/web/20131106123126/http:/www.iskramedical.eu:80/magneto-
`therapy-medical/tesla-stym
`
`
`
`
`LUMENIS EX1018
`Page 8
`
`

`

`
`
`
`inteaver anenive—[http://www.iskramedical.eu/magneto-therapy-medical/tesla-stym |[[Go] AUG
`
`
`
`
`UWaYBAChMMECIME15capures =ul uid
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`4 Aug 2013 - 23 Oct 2016
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`2012
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`LUMENIS EX1018
`Page 9
`
`LUMENIS EX1018
`Page 9
`
`

`

`e
`
` ooo9o
`
`Radio Derm prestige
`Radio Derm
`Cryo Derm prestige
`Cryo Derm
`IPL- PULSED LIGHT THERAPY
`eo Green FLASH
`o FLASHprestige
`o FLASHexclusive
`MAGNETO & FMS THERAPY
`o TESLA Stym
`o Magneto STYM
`o Magneto PULSAR
`© Medio PULSAR
`LASER THERAPY
`© Medio LASER combi
`COMBINATION THERAPY
`© Medio MULTISONO
`
`| Quick search...
`
`TESLAStym - FMS- Functional Magnetic Stimulation
`
`ae
`
`RF 4
`
`Functional Magnetic Stimulation FMS
`Newinnovative joint pain relief treatment
`Noninvasive and painless method
`Easyto reach every part of the body
`Magnetic field strength up to 1,5 Tesla
`Possibility of fixing the applicator
`
`Brochure:S{2ENG | geeSLO! SEHR
`
`Howdoes a magnetic field activate a muscle?
`
`Rapid changes of magnetic field intensity induce an electrical currentin the neuron. This phenomenonis called electromagnetic induction. Once the currentreaches a certain
`value, a so-called neuron action potential is achieved. This causes the neuroncell to depolarize, which eventually leads to a complete muscle contraction.
`
`Whatare the advantages of TESLA Stym FMS,Functional Magnetic Stimulation?
`
`FMSallowsstimulation of deep muscle structures that cannot be reached by FES
`FMSeffectively stimulates muscle tissue without direct skin contact
`FMSispainless, noninvasive and thussuitable for patients where FES cannot be used
`The applicator can be fixed to the body or the therapist can perform therapy manually
`Manually moving the applicator allows motorunits to be found easily, enabling effective stimulation
`Nonegative side effects are knownin theliterature as long as contraindications are taken into account
`
`Indications:
`
`* Musculoskeletal disorders: degenerative arthritis, rheumatoid arthritis, cervical pain, muscle pain
`* Spinal disorders: acute/chronic lumbago, hip gout (sciatica), spina bifida, spondylitis
`* Nerve disorders: peripheral nerve damage
`* Muscle relaxation, frozen shoulder
`* Nerve or musclerehabilitation after fractures
`* Pain control for muscle atrophy, spasm, ankylosis
`* Genitourinary diseases: prostate pain
`* Acute pain control
`* Sports injuries
`
`BASIC SET:
`
`
`1 pe
`- Applicator FMSlarge (1511306)
`1 pe
`- Applicator FMS small (1511305)
`- Fixing rubberstrap 3,2 x 100 cm (1504111) 2 pes
`- Fixingelastic strap 10 x 80 cm (1504311)
`1 pe
`- Mains cable (230V, EURO plug)
`1 pe
`- User's Manual
`1 pe
`
`OPTIONS:
`
`
`- Trolley Green Eco (Code: 4900281)
`
`LUMENIS EX1018
`Page 10
`
`LUMENIS EX1018
`Page 10
`
`

`

`Images:
`
`@@Send an Inquiry
`
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`
`Contacts:
`
`Medical products:
`
`Aesthetics products:
`
`Supplemental products:
`
`Iskra Medical d.0.0.
`
`
`+Ultrasoundtherapy+Ultrasoundtherapy*Therapeutic tables
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`Office:
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`+IPL-HairRemoval
`+ Electrotherapy
`+ Portable massagetables
`
`Otoée Sa, 4244 Podnart
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`
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`
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`
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`E: info@iskramedical.eu
`
`+ IPL - Pulsed Light:MagnifyingLens+ Laser therapy
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`Copyright © Iskra Medical d.o.0. 1991 - 2013. Terms Of Use. Privacy Statement.
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`experience when using it. Privacy Policy.
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`LUMENIS EX1018
`Page 11
`
`LUMENIS EX1018
`Page 11
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`

`
`
`
`
`
`
`
`
`
`
`EXHIBIT B
`EXHIBIT B
`
`LUMENIS EX1018
`Page 12
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`LUMENIS EX1018
`Page 12
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`

`

`https://web.archive.org/web/20170430085613/https:/www.accessdata.fda.gov/cdrh_docs/pdf
`16/K163165.pdf
`
`
`
`
`LUMENIS EX1018
`Page 13
`
`

`

`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`Food and Drug Administration
`10903 New Hampshire Avenue
`Document Control Center - WO66-G609
`Silver Spring, MD 20993-0002
`
`February 16, 2017
`
`BTL Industries, Inc.
`David Chmel
`Director
`47 Loring Drive
`Framingham, Massachusetts 01702
`
`Re: K163165
`Trade/Device Name: AM-100
`Regulation Number: 21 CFR 890.5850
`Regulation Name: Powered Muscle Stimulator
`Regulatory Class: Class II
`Product Code: NGX
`Dated: January 16, 2017
`Received: January 17, 2017
`
`Dear Mr. Chmel:
`
`We have reviewed your Section 510(k) premarket notification of intent to market the device
`referenced above and have determined the device is substantially equivalent (for the indications
`for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
`commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
`devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
`and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
`You may, therefore, market the device, subject to the general controls provisions of the Act. The
`general controls provisions of the Act include requirements for annual registration, listing of
`devices, good manufacturing practice, labeling, and prohibitions against misbranding and
`adulteration. Please note: CDRH does not evaluate information related to contract liability
`warranties. We remind you, however, that device labeling must be truthful and not misleading.
`
`If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
`it may be subject to additional controls. Existing major regulations affecting your device can be
`found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
`publish further announcements concerning your device in the Federal Register.
`
`Please be advised that FDA's issuance of a substantial equivalence determination does not mean
`that FDA has made a determination that your device complies with other requirements of the Act
`or any Federal statutes and regulations administered by other Federal agencies. You must comply
`with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
`Part 807); labeling (21 CFR Part 801 and Part 809; medical device reporting (reporting of
`
`LUMENIS EX1018
`Page 14
`
`

`

`Page 2
`
`- David Chmel
`
`medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
`as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
`electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
`1050.
`
`If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and
`Part 809), please contact the Division of Industry and Consumer Education at its toll-free number
`(800) 638-2041 or (301) 796-7100 or at its Internet address
`http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
`the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
`807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
`CFR Part 803), please go to
`http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
`of Surveillance and Biometrics/Division of Postmarket Surveillance.
`
`You may obtain other general information on your responsibilities under the Act from the
`Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)
`796-7100 or at its Internet address
`http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
`
`Sincerely,
`
`Michael J. Hoffmann -S
`
`for
`
`Carlos L. Peña, PhD, MS
`Director
`Division of Neurological
`and Physical Medicine Devices
`Office of Device Evaluation
`Center for Devices and Radiological Health
`
`Enclosure
`
`LUMENIS EX1018
`Page 15
`
`

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`
`LUMENIS EX1018
`Page 16
`
`

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`
`
`510(k) Summary
`
`
`
`General Information
`
`Sponsor:
`
`
`
`
`
`Applicant:
`
`
`
`
`
`Contact Person:
`
`
`
`Summary Preparation
`Date:
`
`BTL Industries, Inc.
`47 Loring Drive
`Framingham, MA 01702
`Tel: +1-866-285-1656
`Fax: +1-888-499-2502
`
`BTL Industries, Inc.
`47 Loring Drive
`Framingham, MA 01702
`Tel: +1-866-285-1656
`Fax: +1-888-499-2502
`
`David Chmel
`BTL Industries, Inc.
`chmel@btlnet.com
`
`February 16, 2017
`
`Device Name
`
`
`
`Trade/Proprietary Name:
`
`AM-100
`
`Primary Classification Name:
`
`Stimulator, Muscle, Powered
`
`Classification Regulation:
`
`21 CFR 890.5850, Class II
`
`Classification Product Code:
`
`NGX
`
`
`
`Legally Marketed Predicate Devices
`
`The AM-100 is a state-of-the-art magnetic device with accessories, and is substantially
`equivalent to the current product that is already cleared for distribution in the USA under the
`following 510(k) Premarket Notification number:
`
`(cid:120) Torc Body (K131291)
`
`
`
`
`510(k) Summary - Page 1 of 6
`
`LUMENIS EX1018
`Page 17
`
`

`

`
`
`
`
`The HPM-6000 device was used as a reference device to support the determination of
`substantial equivalence. The HPM-6000 is cleared (K160992) as a PMS device because it
`elicits a muscle contraction.
`
`Product Description
`
`The AM-100 is a non-invasive therapeutic device. The device produces electromagnetic field
`that interacts with the tissues of the human body. By muscle stimulation, the AM-100 helps to
`strengthen and firm the abdomen, buttocks and thighs.
`
`The AM-100 is equipped with a color touch screen with wide view angle that significantly
`facilitates the use of the device. The on-screen information guides the user step-by-step
`through the entire therapy procedure. The therapeutic parameters are easily set using the
`touch screen, buttons and knob on the device. During the therapy the device keeps
`information about the applied therapy type, remaining therapy time and main therapy
`parameters on the screen.
`
`The AM-100 device has already been cleared by the FDA for muscle stimulation under the
`device name HPM-6000 (K160992).
`
`Indications for Use
`
`AM-100 is indicated to be used for:
`• Improvement of abdominal tone, strengthening of the abdominal muscles,
`
`development of firmer abdomen.
`• Strengthening, Toning and Firming of buttocks and thighs.
`
`
`
`Non-clinical Testing
`
`The AM-100 device has been thoroughly evaluated for electrical safety. The device has been
`found to comply with the following applicable medical device safety standards:
`
`
`
`IEC 60601-1
`
`Medical electrical equipment – Part 1: General requirements for basic
`safety and essential performance
`IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for
`basic safety and essential performance - Collateral standard:
`Electromagnetic compatibility – Requirements and tests
`IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for
`basic safety and essential performance – Collateral standard: Usability
`IEC 60601-2-10 Medical Electrical Equipment – Part 2-10: Particular Requirements for
`the Basic Safety and Essential Performance of Nerve and Muscle
`Stimulators
`
`
`510(k) Summary – Page 2 of 6
`
`LUMENIS EX1018
`Page 18
`
`

`

`
`
`
`
`Medical devices - Application of usability engineering to medical
`devices
`Medical device software – Software life cycle processes
`Medical devices – Application of risk management to medical devices
`
`IEC 62366
`
`IEC 62304
`
`ISO 14971
`
`
`
`Clinical testing
`
`The substantial equivalence determination for the AM-100 is not based on clinical testing.
`The device safety and efficacy was demonstrated by comparison of technical characteristics
`between the AM-100 and the predicate device.
`
`
`
`Summary of Clinical and Non-clinical testing
`
`Nonclinical test have been conducted to evaluate the AM-100 performance, and results
`confirm that the device performs as intended and in a similar manner compared to the
`predicate. Thus, the AM-100 is substantially equivalent to the predicate devices.
`
`
`
`Comparison with the Predicate Device
`
`510(k) number
`
`Not Assigned
`
`K131291
`
`Device name
`
`Company name
`
`AM-100
`
`BTL Industries, Inc.
`
`Torc Body
`
`Johari Digital HealthCare
`Ltd.
`
`Significant
`Difference
`
`Product Code
`and Regulation
`
`Physical Medicine
`
`Physical Medicine
`
`21 CFR 890.5850
`NGX – Stimulator, Muscle,
`Powered, Muscle
`Conditioning
`
`21 CFR 890.5850
`NGX – Stimulator, Muscle,
`Powered, Muscle
`Conditioning
`
`None
`
`
`510(k) Summary – Page 3 of 6
`
`LUMENIS EX1018
`Page 19
`
`

`

`
`
`
`
`510(k) number
`
`Not Assigned
`
`K131291
`
`Device name
`
`Company name
`
`AM-100
`
`BTL Industries, Inc.
`
`Torc Body
`
`Johari Digital HealthCare
`Ltd.
`
`Significant
`Difference
`
`Indications for
`Use
`
`AM-100 is indicated to be
`used for:
`(cid:120) Improvement of
`abdominal tone,
`strengthening of the
`abdominal muscles,
`development of firmer
`abdomen.
`(cid:120) Strengthening, Toning
`and Firming of buttocks
`and thighs.
`
`TORC BODY is indicated to
`be used for:
`(cid:120) Improvement of abdominal
`tone, for strengthening of
`the abdominal muscles,
`for development of firmer
`abdomen.
`(cid:120) Strengthening, Toning and
`Firming of buttocks and
`thighs.
`
`None
`
`Primary Function Muscle stimulation
`
`Muscle stimulation
`
`None
`
`Principle of
`Action
`
`Initiating action potential of
`nerves results in muscle
`contraction
`
`Initiating action potential of
`nerves results in muscle
`contraction
`
`None
`
`Clinical Use
`
`Prescription use
`
`Home use
`
`Electrical
`Protection
`
`Class II, BF
`
`Class II, BF
`
`User Interface
`
`Touch screen
`
`Touch screen
`
`Firmware
`Controlled
`
`Yes
`
`Yes
`
`Type of Energy
`
`Magnetic field
`
`Electrical
`
`Magnetic Field
`Intensity
`
`Applicator 299-1: 0.5–1.8 T
`Applicator 299-2: 0.7–2.5 T
`
`N/A
`
`Not
`Significantly
`different
`
`None
`
`None
`
`None
`
`Not
`Significantly
`different
`
`N/A
`
`Type of Operation Continuous
`
`Continuous
`
`None
`
`Pulse Repetition
`Rate
`
`1 – 150 Hz
`
`1 - 200 Hz
`
`Not
`significantly
`different
`
`
`510(k) Summary – Page 4 of 6
`
`LUMENIS EX1018
`Page 20
`
`

`

`
`
`
`
`510(k) number
`
`Not Assigned
`
`K131291
`
`Device name
`
`Company name
`
`AM-100
`
`BTL Industries, Inc.
`
`Torc Body
`
`Johari Digital HealthCare
`Ltd.
`
`Significant
`Difference
`
`Pulse Duration
`
`280 ± 20% µs
`
`Pulse Amplitude
`
`0 – 100%
`
`290 µs
`
`0 – 100%
`
`Current Strength
`
`N/A
`
`Up to 102 mA
`
`Induced Current
`in the Tissue
`
`28-30 mA
`
`28 mA
`
`Selection of
`parameters
`(Intensity, Time)
`
`Yes
`
`Therapy Time
`
`Up to 60 min
`
`Yes
`
`1 – 60 min
`
`Shape of
`Stimulation Pulse
`
`Symmetrical Biphasic Sine
`Wave
`
`Symmetrical Biphasic
`Square Wave
`
`Energy Source
`
`100 – 240 V AC, 50–60 Hz
`
`24 V DC Battery pack and
`Adaptor: 100 – 240 V AC,
`50–60 Hz
`
`None
`
`None
`
`N/A
`
`Not
`significantly
`different
`
`None
`
`None
`
`Not
`significantly
`different
`
`Not
`significantly
`different
`
`Not
`significantly
`different
`
`Not
`significantly
`different
`
`System
`Dimensions
`(W×H×D)
`
`Ambient
`Temperature
`
`Environmental
`Specifications
`
`
`
` 500×970×580 mm
`(20×38×23 in)
`
`152x102x203 mm
`
`(6×4×8 in)
`
`-10°C to +55°C
`
`0°C to +44°C
`
`For indoor use only
`
`For indoor use only
`
`None
`
`Substantial Equivalence
`
`The AM-100 device has the same indications for use and similar technological characteristics
`and principles of operation as its predicate device.
`
`One of the technological differences between the subject and the predicate device includes
`type of energy used. However, the mechanism of action of the electrical stimulator and this
`
`
`510(k) Summary – Page 5 of 6
`
`LUMENIS EX1018
`Page 21
`
`

`

`
`
`
`
`kind of magnetic device is the same. Further, the predicate device is intended for a home
`use, while the subject device is intended for prescription use only. There are devices with a
`similar technology that are already cleared by the FDA as a prescription use devices. The
`AM-100 device and its predicate device differ in the shape of stimulation pulse, however that
`feature does not influence the muscle contraction stimulation. The last technological
`difference between the subject and the predicate device is pulse repetition rate. The pulse
`repetition rate of the subject device is within the range of the commonly used ones for
`devices intended for muscle stimulation.
`
`The energies coming out of the devices can not be directly compared due to the fact the
`predicate device is a contact one while the subject device is the non-contact device.
`Comparable are electrical currents induced directly in the targeted tissue.
`
`The current induced by the magnetic field (subject device) is almost identical compared to the
`predicate device.
`
`
`
`The technological differences between the AM-100 and the predicate device do not raise new
`types of safety or effectiveness questions.
`
`
`
`Conclusion
`
`Based upon the intended use and known technical information provided in this pre-market
`notification, the AM-100 device has been shown to be substantially equivalent to currently
`marketed predicate device.
`
`
`
`
`510(k) Summary – Page 6 of 6
`
`LUMENIS EX1018
`Page 22
`
`

`

`https://web.archive.org/web/20170208042030/https:/www.accessdata.fda.gov/cdrh_docs/pdf
`16/K160992.pdf
`
`
`
`
`LUMENIS EX1018
`Page 23
`
`

`

`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`Food and Drug Administration
`10903 New Hampshire Avenue
`Document Control Center - WO66-G609
`Silver Spring, MD 20993-0002
`
`October 21, 2016
`
`BTL Industries, Inc.
`Jan Zarsky
`Director
`47 Loring Drive
`Framingham, Massachusetts 01702
`
`Re: K160992
`Trade/Device Name: HPM-6000
`Regulation Number: 21 CFR 890.5850
`Regulation Name: Powered Muscle Stimulator
`Regulatory Class: Class II
`Product Code: IPF
`Dated: March 21, 2016
`Received: April 8, 2016
`
`Dear Jan Zarsky:
`
`We have reviewed your Section 510(k) premarket notification of intent to market the device
`referenced above and have determined the device is substantially equivalent (for the indications
`for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
`commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
`devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
`and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
`You may, therefore, market the device, subject to the general controls provisions of the Act. The
`general controls provisions of the Act include requirements for annual registration, listing of
`devices, good manufacturing practice, labeling, and prohibitions against misbranding and
`adulteration. Please note: CDRH does not evaluate information related to contract liability
`warranties. We remind you, however, that device labeling must be truthful and not misleading.
`
`If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
`it may be subject to additional controls. Existing major regulations affecting your device can be
`found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
`publish further announcements concerning your device in the Federal Register.
`
`Please be advised that FDA's issuance of a substantial equivalence determination does not mean
`that FDA has made a determination that your device complies with other requirements of the Act
`or any Federal statutes and regulations administered by other Federal agencies. You must comply
`with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
`Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-
`related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
`
`LUMENIS EX1018
`Page 24
`
`

`

`Page 2
`
`- Jan Zarsky
`
`the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product
`radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
`
`If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
`contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041
`or (301) 796-7100 or at its Internet address
`http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
`the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
`807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
`CFR Part 803), please go to
`http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
`of Surveillance and Biometrics/Division of Postmarket Surveillance.
`
`You may obtain other general information on your responsibilities under the Act from the
`Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)
`796-7100 or at its Internet address
`http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
`
`Sincerely yours,
`
`William J.
`Heetderks -A
`
`Digitally signed by William J. Heetderks -
`A
`DN: c=US, o=U.S. Government, ou=HHS,
`ou=NIH, ou=People,
`0.9.2342.19200300.100.1.1=0010149848,
`cn=William J. Heetderks -A
`Date: 2016.10.21 16:12:18 -04'00'
`
`for
`
`Carlos L. Peña, PhD, MS
`Director
`Division of Neurological
`and Physical Medicine Devices
`Office of Device Evaluation
`Center for Devices and Radiological Health
`
`Enclosure
`
`LUMENIS EX1018
`Page 25
`
`

`

`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`Food and Drug Administration
`
`Indications for Use
`
`Form Approved: OMB No. 0910-0120
`
`Expiration Date: January 31, 2017
`
`See PR