DEPILASE TWIN YAG LASER SYSTEM

K020697 · Depilase Group , Ltd. · GEX · Apr 12, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K020697
• Device Name: DEPILASE TWIN YAG LASER SYSTEM
• Applicant: Depilase Group , Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 12, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The DEPILASE TWIN YAG Laser System is intended for the coagulation and haemostasis of vascular lesions (1064 and 532 nm wavelengths) and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (1064 nm wavelength).

Device Story

The DEPILASE TWIN YAG Laser System is a flashlamp-pumped Nd:YAG laser for dermatological surgery. It generates 1064 nm laser radiation, with an optional frequency-doubling Second Harmonic Crystal (SHC) to produce 532 nm. A red diode aiming beam is co-axially aligned. Energy is delivered via an optical fiber and focusing handpiece in non-contact mode. The system includes a high-voltage power supply, internal water-to-air heat exchanger cooling, and a microprocessor-based controller for parameter selection. Operated by clinicians in a clinical setting, the device allows for precise coagulation of vascular lesions and permanent hair reduction. The microprocessor regulates laser functions, ensuring controlled energy delivery to the target tissue. Benefits include effective treatment of vascular lesions and hair reduction across all Fitzpatrick skin types.

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 laser; 1064 nm fundamental wavelength; 532 nm frequency-doubled wavelength via Second Harmonic Crystal (SHC); optical fiber delivery; focusing handpiece; internal closed-loop water-to-air heat exchanger; microprocessor-controlled; Class I aiming beam.

Indications for Use

Indicated for coagulation and haemostasis of vascular lesions (1064/532 nm) and permanent hair reduction (1064 nm) in patients Fitzpatrick skin types I-VI, including suntanned 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

• Laserscope Lyra (K990718)
• Altus Medical Aesthetic CoolGlide (K991798)
• Fotona Dualis KTP (K011939)

Submission Summary (Full Text)

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K020697 //

### Appendix E

### 510 (k) Summary

# APR 1 2 2002

- General Information: 1.
・・

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

#### I. Description

The DEPILASE TWIN YAG 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, with the option of frequency doubling the fundamental laser wavelength, from 1064 nm to 532 nm. The frequency doubling wavelength is obtained by warelonging with the laser radiation through a special crystal called Second Harmonic Crystal (SHC). After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using (SHO). 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 TWIN YAG 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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The DEPILASE TWIN YAG Laser System is indicated for the coagulation and haemostasis of vascular lesions and/or the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types.

### III. Summary of Substantial Equivalence

Depilase believes that its DEPILASE TWIN YAG Laser System is substantially equivalent, Doprade Done res that laser emission , to the Laserscope Lyra (K990718) and Altus Medical Aesthetic CoolGlide (K991798) Nd: YAG lasers, previously cleared for both the coagulation and haemostasis of vascular lesions and/or the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I - VI, including suntanned skin types, and regarding the 532 nm laser President to the Fotona Dualis KTP ( K011939) previously cleared for the coagulation and haemostasis of vascular lesions

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

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

The DEPILASE TWIN YAG 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 TWIN YAG 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 1 2 2002

Depilase Group Ltd. c/o Ms. Pamela Gwynn Engineering Team Leader Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709-3995

Re: K020697

Trade/Device Name: Depilase Twin YAG Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 21, 2002 Received: March 28, 2002

Dear Ms. Gwynn:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your because be device is substantially equivalent (for the indications ferenced above and have sure) to legally marketed predicate devices marketed in interstate for use stated in the exciesems 776, the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de vices that have boon require approval of a premarket approval application (PMA). and Cosmetic (110. (110.) that to nevice, subject to the general controls provisions of the Act. The r ou may, mererere, mains 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 If your device is exassinos (tional controls. Existing major regulations affecting your device can may or subject to basil as a substions, 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 r lease of acribed that I branination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I edelar statutes and sequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of A rate 677) its ensight (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 – Ms. Pamela Gwynn

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,

Muriam C. Provost

Cor 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): _ k 020697

Device Name:

# DEPILASE TWIN YAG LASER SYSTEM

Indications For Use:

The DEPILASE TWIN YAG Laser System is intended for the coagulation and haemostasis of vascular lesions( 1064 and 532 nm wavelengths) and the removal and permanent reduction of unwanted hair in Fitzpatrick skin types I -VI, including suntanned skin types (1064 nm wavelength).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Miriam C Provost*

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

| Prescription Use | <div> <p>✓</p> </div> |
|----------------------|-----------------------|
| (per 21 CFR 801.109) | |

| 510(k) Number | K020697 |
|---------------|-----------------------------|
| OR | Over The Counter Use ______ |

Premarket Notification for DEPILASE TWIN YAG Laser System