MYTHOS 500

K030805 · Msq (M2) , Ltd. · GEX · May 21, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030805
• Device Name: MYTHOS 500
• Applicant: Msq (M2) , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MYTHOS 500™ Hair Removal Diode Laser is intended for hair removal and permanent hair reduction. The MYTHOS 500™ System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Device Story

System delivers pulsed 810nm infrared laser light for hair removal; selectable fluence 5-60J/cm2; two pulse modes (Long pulse, Pulse). Console connects to handpiece via umbilical cord; 10x12mm handpiece tip features integrated cooling. Operator (physician/clinician) initiates energy via simultaneous handpiece trigger and footswitch activation. System parameters controlled via console LCD and buttons. Device provides permanent hair reduction by targeting hair follicles; cooling tip minimizes thermal skin damage. Used in clinical settings.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological comparison to predicate and safety/performance testing (bench testing).

Technological Characteristics

Diode laser system; 810nm wavelength; 10x12mm handpiece tip; integrated cooling. Complies with 21 CFR 1040.10, 1040.11 (Class IV), IEC 60601-1, IEC 60601-1-2, IEC 60825-1, IEC 601-2-22. Console-based with LCD interface.

Indications for Use

Indicated for hair removal and permanent hair reduction in patients of all skin types (Fitzpatrick I-VI), including tanned skin.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• LightSheer (Coherent Star) (K001746)
• LightSheer (Coherent Star) (K003614)

Submission Summary (Full Text)

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## 510(K) SUMMARY

## MYTHOS 500™ DIODE LASER SYSTEM

## 510(k) Number K__030805

Applicant's Name: Msq(M2) Ltd. 7 Haeshel St. P.O.B 3021 Caesarea Industrial Park 38900 Israel Tel: [phone] Fax: [phone] e-mail: [e-mail]

- Contact Person: Arava Hacohen Push-med Ltd. 117 Ahuzah St. Ra'anana 43373. Israel Tel: [phone] Fax: [phone] e-mail: arava(@push-med.com
Date Prepared: February 2003

Trade Name: MYTHOS 500™ Hair Removal Diode Laser

Classification Name: Laser Instrument, Surgical, powered

- Classification: FDA has classified a laser device as a class II device (product code GEX) and it is reviewed by the General & Plastic Surgery Panel.
- Msq(M2) Ltd. believes that the MYTHOS 500TM Predicate Device: Diode Laser System is substantially equivalent to the LightSheer™ (Coherent Star) cleared under K001746 and K003614 in terms of intended use and indications for use, performance, technological characteristics and user interface.
- Performance Standards: The MYTHOS 500™ Hair Removal Diode Laser complies with U.S. Federal Performance Standards 21 CFR 1040.10 and 21 CFR 1040.11 for class IV Laser Products.

In addition, the device complies with the European Medical Directive 93/42/EEC concerning medical devices (Annex II) and with the voluntary standards, IEC 60601-1, IEC 60601-1-2, IEC-60825-1 and IEC 601-2-22, as described in Section 5.

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- Intended Use / Indication for Use: The MYTHOS 500™ Hair Removal Diode Laser is intended for hair removal and permanent hair reduction. The MYTHOS 500™ System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
- Device Description: The MYTHOS 500™ system delivers pulsed infrared laser light with a 810nm±10% wavelength and a selectable fluence of 5-60J/cm2. The system enables two pulse modes: Long pulse and Pulse. The pulsed energy is delivered through a 10x12mm handpiece tip. The complete system consists of console and a handpiece connected to the system by an umbilical cord. The handpiece is pressed against the patient's skin and a pulse of laser is delivered. To initiate energy output the system requires simultaneous activation of the handpiece trigger and the footswitch. The handpiece tip is cooled to provide continuous skin cooling. Laser parameters and other system features are controlled from the Operating Buttons and LCD screen on top of the console, which provide interface with the system computer.
- Substantial Equivalence: There are no unique applications, indications, material or specifications presented herein. Evidence of equivalence has been demonstrated through:
- The MYTHOS 500™ intended use and indications for use were . previously cleared by FDA for the predicate device (LightSheer).
- . The technical characteristics of the MYTHOS 500™ are similar to those of the LightSheer™.
- . Laser output values of the MYTHOS 500™ are well within previous cleared values of the LightSheer™.
- . Safety and performance testing.

Therefore, we believe that the MYTHOS 500™ Hair Removal Diode Laser is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 21 2003

Msq (M4) Ltd. c/o Mr. Arava Hacohen Push-med Ltd. 117 Ahuzah St. Ra'ananna 43373, Israel

Re: K030805 Trade/Device Name: MYTHOS 500™ Hair Removal Diode laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 13, 2003 Received: March 13, 2003

Dear Mr. Hacohen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Arava Hacohen

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Sincerely yours,

Mark A. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

MYTHOS 500™ Hair Removal Diode Laser System Device Name:

Indications for Use:

The MYTHOS 500™ Hair Removal Diode Laser is intended for hair removal and permanent hair reduction. The MYTHOS 500™ System is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

510(k) Number `K030805`

Prescription Use
(Per 21 CFR 801.109)

OR

Over the Counter Use

*Mark A Melkum*
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

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510(k) Number `K030805