DEPILASE TRIO LASE LASER SYSTEM

K030508 · Depilase Group , Ltd. · GEX · May 20, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030508
• Device Name: DEPILASE TRIO LASE LASER SYSTEM
• Applicant: Depilase Group , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DEPILASE TRIO LASE Laser System is intended for the coagulation and haemostasis of vascular lesions ( 532 and 1064 nm ), the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (755 and 1064 nm) and the dermatological applications for the non invasive treatment of facial wrinkles (1064 nm).

Device Story

The DEPILASE TRIO LASE Laser System is a multi-wavelength surgical laser platform utilizing Nd:YAG (1064 nm) and Alexandrite (755 nm) crystals, plus 532 nm emission. Flashlamp-pumped optical cavities generate therapeutic pulses; a red diode aiming beam is co-aligned via beamsplitter. Energy is delivered via optical fiber to a non-contact focusing handpiece. Operated by clinicians in a dermatological setting, the system features a microprocessor-based controller for parameter selection. The device provides thermal coagulation and hemostasis for vascular lesions, hair reduction, and wrinkle treatment. Clinical benefit is achieved through controlled laser-tissue interaction, with thermal management provided by an internal closed-loop water-to-air heat exchanger.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and performance similarities to legally marketed predicate devices.

Technological Characteristics

Flashlamp-pumped Nd:YAG (1064 nm) and Alexandrite (755 nm) laser rods; 532 nm emission capability. Features include microprocessor-based control, internal closed-loop water-to-air heat exchanger, and optical fiber delivery with focusing handpiece. Class I aiming beam. Non-contact operation.

Indications for Use

Indicated for coagulation and haemostasis of vascular lesions, permanent hair reduction in Fitzpatrick skin types I-VI (including suntanned skin), and non-invasive treatment of facial wrinkles.

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

• Laserscope Lyra (K990718, K020021)
• Altus Medical Aesthetic CoolGlide (K991798)
• Fotona Dualis KTP (K011939)
• Candela GenteLASE GL (K994260)
• GenteLASE II (K984601)
• Cynosure Apogee TSK (K992757)

Submission Summary (Full Text)

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Appendix E

:

510 (k) Summary

MAY 2 0 2003

K030508

1. General Information:

| Company: | Depilase Group Ltd<br>One Canada Square<br>Canary Wharf<br>London E14 5DY<br>United Kingdom |
|--------------------|---------------------------------------------------------------------------------------------|
| Contact Person: | Dr. Mario Luca Russo |
| Preparation: | 11-15-02 |
| Device Trade Name: | DEPILASE TRIO LASE Laser System |
| Common Name: | Long Pulsed Nd:YAG and Alexandrite Surgical, Powered, Laser<br>79—GEX<br>21 CFR 878-48 |

## I. Description

The DEPILASE TRIO LASE Laser System is based on Nd: YAG and Alexandrite Jaser technology. Within the same system, one optical cavity contains the Nd: YAG crystal, and another optical cavity contains the Alexandrite crystal, which are activated by means of the use of a flashlamp. After each cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided down an individual optical fibre delivery system to a focusing handpiece. The laser is used in a noncontact mode.

The DEPILASE TRIO LASE Laser System is designed with 6 major sub-systems:

- a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse.
- b) A cooling system consisting of an internal water flow circuit together with water to air heat exchanger.
- c) An Nd: YAG laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
- d) An Alexandrite laser rod, capable of generating optical pulses at a frequency up to 2 Hz.
- e) Two optical delivery systems, interfacing the energy from each laser cavity to the patient via an indipendent optical fibre and focusing handpiece.
- The microprocessor based controller which regulates the functions of the laser and allows f) parameter selection by the user.

Premarket Notification for DEPILASE TRIO LASE Laser System

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The DEPILASE TRIO LASE Laser System is indicated for the coagulation and haemostasis of vascular lesions, the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin and the dermatological applications for the non invasive treatment of facial wrinkles

## III. Summary of Substantial Equivalence

Depilase believes that its DEPILASE TRIO LASE Laser System is substantially equivalent, regarding the Nd:YAG laser emission, to the Laserscope Lyra (K990718. K020021), and Altus Medical Aesthetic CoolGlide (K991798) Nd: YAG Lasers previously cleared for both the coagulation and hemostasis of vascular lesions, the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types and the non invasive treatment of wrinkles, regarding the 532 nm laser emission to the Fotona Dualis KTP (K011939), previously cleared for the coagulation and haemostasis of vascular lesions and regarding the Alexandrite laser emission, to the Candela GenteLASE GL (K994260). GenteLASE II (K984601) and the Cynosure Apogee TSK (K992757) Alexandrite lasers, all previously cleared for the removal of unwanted hair in Fitzpatrick skin types I - IV

They therefore have the same Intended Use as the DEPILASE TRIO LASE Laser System.

Technologically, the predicate devices have identical characteristics to the DEPILASE TRIO LASE Laser System, all comprising a flashlamp pumped Nd: YAG laser rod generating light at a wavelength of 1064 nm or 532nm, or a flashlamp pumped Alexandrite laser rod generating light at a wavelength of 755 nm which is subsequently delivered to the patient via an individual optical fibre delivery system and focusing handpiece.

The DEPILASE TRIO LASE Laser System output characteristics are very similar to those of the predicate devices.

All lasers are microprocessor controlled devices.

All lasers utilize Class I aiming beams which pose no hazard to the user.

All systems utilize an internal closed loop water-air heat exchange circuit for optimal thermal control of the laser cavity.

The risk and benefits of the DEPILASE TRIO LASE Laser System are comparable to the predicate devices when used for similar clinical applications.

It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

MAY 2 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Mario Luca Russo Director of Research and Development Depilase Group Ltd. One Canada Square Canary Wharf London E14 5DY UK

Re: K030508

Trade/Device Name: Depilase Trio Lase Laser System 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: January 5, 2003 Received: February 19, 2003

Dear Dr. Russo:

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 - Dr. Mario Luca Russo

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. Mikkelsen

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 STATEMENT

510 (K) Number (if known):

510 (K) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name:

DEPILASE TRIO LASE LASER SYSTEM

Indications For Use:

The DEPILASE TRIO LASE Laser System is intended for the coagulation and haemostasis of vascular lesions ( 532 and 1064 nm ), the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (755 and 1064 nm) and the dermatological applications for the non invasive treatment of facial wrinkles (1064 nm).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of General, Restorative and Neurological Devices

| 510(k) Number: | K030508 |
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|----------------|---------|

| Prescription Use<br>(per 21 CFR 801.109) | OR | Over The Counter Use |
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Premarket Notification for DEPILASE TRIO LASE Laser System