DEPILASE YAG LASE PLUS LASER SYSTEM

K030506 · Depilase Group , Ltd. · GEX · May 9, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030506
• Device Name: DEPILASE YAG LASE PLUS LASER SYSTEM
• Applicant: Depilase Group , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DEPILASE YAG LASE PLUS Laser System is intended for the coagulation and haemostasis of vascular lesions, the removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI and for the use in dermatological applications for the treatment of facial wrinkles.

Device Story

The DEPILASE YAG LASE PLUS is a flashlamp-pumped Nd:YAG laser system (1064 nm) for dermatological use. It consists of a high-voltage power supply, internal water-to-air cooling system, Nd:YAG laser rod, optical fiber delivery system, and focusing handpiece. A red diode aiming beam is integrated via a beamsplitter. The device is operated by a clinician in a non-contact mode. A microprocessor-based controller manages laser parameters and system functions. The laser energy is delivered to the patient to treat vascular lesions, remove hair, or reduce facial wrinkles. The system provides thermal control of the laser cavity via a closed-loop heat exchange circuit.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparison to the predicate device.

Technological Characteristics

Flashlamp-pumped Nd:YAG laser; 1064 nm wavelength; pulse frequency up to 3 Hz; optical fiber delivery system; focusing handpiece; microprocessor-controlled; internal closed-loop water-to-air heat exchanger; Class I red diode aiming beam.

Indications for Use

Indicated for coagulation and haemostasis of vascular lesions, removal and permanent reduction of unwanted hair (Fitzpatrick skin types I-VI), and 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 (K020021)

Submission Summary (Full Text)

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# MAY - 9 2003

#### Appendix E 510 (k) Summary :

- 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: | 12-01-02 | |
| Device Trade Name: | DEPILASE YAG LASE PLUS Laser System | |
| Common Name: | Long Pulsed Nd:YAG Surgical, Powered, Lase<br>79 -GEX<br>21 CFR 878-48 | |

## I. Description

The DEPILASE YAG LASE PLUS Laser System is based on Nd: YAG laser technology. Within the system, an optical cavity contains the Nd: YAG crystal. which is activated by means of the use of a flashlamp. After the 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 optical fibre delivery system to a focusing handpiece. The laser is used in a non-contact mode.

The DEPILASE YAG LASE PLUS Laser System is designed with 5 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 3 Hz
- d) An optical delivery system, interfacing the energy from the laser to the patient via an optical fibre and focusing handpiece.
- e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

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K030506 2 of 2

#### II. Intended Use

The DEPILASE YAG LASE PLUS Laser System is indicated for the use in dermatological applications for the treatment of facial wrinkles.

#### III. Summary of Substantial Equivalence

Depilase believes that its DEPILASE YAG LASE PLUS Laser System is substantially equivalent to the Laserscope Lyra (K020021) Nd: YAG laser, previously cleared for the use in dermatological applications for the treatment of facial wrinkles (1064 nm emission).

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

Technologically, the predicate device has identical characteristics to the DEPILASE YAG LASE PLUS Laser System, comprising a flashlamp pumped Nd: YAG laser rod generating light at a wavelength of 1064nm, which is subsequently delivered to the patient via an optical fibre delivery system and focusing handpiece.

The DEPILASE YAG LASE PLUS Laser System output characteristics are very similar to those of 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 YAG LASE PLUS Laser System are comparable to the predicate device 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 Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2003

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

Re: K030506

Trade/Device Name: DEPILASE YAG LASE PLUS 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 Mr. 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,

Miriam C. Provost

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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# APPENDIX F

#### INDICATIONS FOR USE STATEMENT

510 (K) Number (if known): _ K0305066

Device Name:

DEPILASE YAG LASE PLUS LASER SYSTEM

Indications For Use:

The DEPILASE YAG LASE PLUS Laser System is intended for the coagulation and haemostasis of vascular lesions, the removal and permanent reduction of unwanted hair in Fitzpatrick skin type I - VI and for the use in dermatological applications for the treatment of facial I r richkes

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|-----------------------------------------------------------|----------------------|
| | <i>Miriam C. Provost</i> | |
| | (Division Sign-Off) | |
| | Division of General, Restorative and Neurological Devices | |
| 510(k) Number | K030506 | |
| Prescription Use (per 21 CFR 801.109) | OR | Over The Counter Use |

Premarket Notification for DEPILASE YAG LASE PLUS Laser System