CANDELA GENTLELASE GL DERMATOLOGICAL LASER

K994260 · Candela Corp. · GEX · May 26, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K994260
• Device Name: CANDELA GENTLELASE GL DERMATOLOGICAL LASER
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 26, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Candela GentleLASE GL Dermatology Laser is indicated for the following uses : - The Photocoagulation of Dermatological vascular lesions. 1. - Temporary hair reduction. 2. - Stable long-term, or permanent hair reduction through 3 . selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. It is also intended for the photocoagulation of dermatological vascular lesions.

Device Story

Candela GentleLASE GL is a long-pulse Alexandrite laser system emitting 755 nm energy; used for photocoagulation of vascular lesions and hair reduction. System components include high-voltage power supply, optical laser head, circulator, optical delivery system, software control, and Dynamic Cooling Device (DCD). DCD cools skin pre-treatment to minimize thermal damage and pain. Operated by clinicians in dermatological settings; users select parameters via onboard control panel. Laser energy targets melanin in hair follicles to achieve stable long-term or permanent hair reduction. Safety interlocks protect patients and operators. Clinical trial data supports hair reduction efficacy and safety.

Clinical Evidence

Clinical trial conducted to evaluate hair reduction efficacy and safety. Results demonstrated that the GentleLASE Laser System removes unwanted hair without raising unexpected safety issues.

Technological Characteristics

Alexandrite crystal laser; 755 nm wavelength; near-infrared energy. Includes Dynamic Cooling Device for skin protection. Features high-voltage power supply, optical delivery system, and software control system. Safety interlocks included. Class II device.

Indications for Use

Indicated for photocoagulation of dermatological vascular lesions and temporary or permanent hair reduction via selective targeting of melanin in hair follicles.

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

• Candela GentleLASE GL laser (K974381)
• Candela GentleLASE hair count reduction (K981351)
• Star Medical Technologies, Inc. LightSheer™ Laser (K982940)
• Palomar Medical Technologies, Inc. EpiLaser® (K980517)
• Laserscope Lyra™ Laser System (K990903)

Submission Summary (Full Text)

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# 510(k) Summary

## General Information:

This 510(k) is to provide notification of substantial equivalence for the Candela GentleLASE GL Laser System, which is substantially equivalent to previously marketed devices intended for the Photocoagulation of Dermatological vascular lesions and for the permanent reduction of hair counts.

| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in General and<br>Plastic Surgery and in Dermatology) |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Dermatology Laser, Long pulse Alexandrite Laser |
| Predicate Devices: | Candela GentleLASE GL laser cleared under 510(k) 974381, cleared on<br>February 10, 1998. The hair count reduction indication as included in 510(k)<br>K981351, was cleared on July 13, 1998. The Star Medical Technologies, Inc.<br>LightSheer™ Laser, which was cleared for the indication of permanent hair<br>reduction under 510(k) number K982940. The Palomar Medical Technologies,<br>Inc. EpiLaser®, was cleared for the indication of permanent hair reduction<br>under 510(k) number K980517. The Laserscope Lyra™ Laser System, was<br>cleared for treatment of vascular lesions under 510(k) number K990903. |

### Description:

The Candela (Modified) GentleLASE GL Laser utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed to the targeted area via an optical fiber/handpiece delivery system. The Dynamic Cooling Device functions to cool the skin prior to laser treatment, minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela GentleLASE Lasers are designed with six major components:

- High voltage power supply and modulator system 1.
- 2. Optical laser head
- Circulator system 3.
- 4. Optical delivery system
- Software control system 5.
- 6. Dynamic cooling device

The Candela GentleLASE Lasers are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

The intended uses of the laser system are for the Photocoagulation of Dermatological vascular lesions and for Temporary hair reduction. It is also intended to effect stable long-term or permanent, hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime.

#### Testing:

A clinical trial demonstrated that the GentleLASE Laser System removes unwanted hair without raising any unexpected safety issues.

# Summary of Substantial Equivalence:

The Candela GentleLASE Lasers have the same intended use, utilize the same operating principles and match key design aspects, including similar spotsize, the same wavelength and the same maximum delivered power as the predicate devices.

On the basis of similarities in methods of assembly, method of operation, intended uses, and clinical data Candela believes that its Candela GentleLASE Laser System is substantially equivalent to the predicate devices.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 6 2000

Mr. Jay Caplan Vice President Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778

K994260 Re:

Trade Name: Candela GentleLASE GL Dermatology Laser Regulatory Class: II Product Code: GEX Dated: February 29, 2000 Received: March 1, 2000

Dear Mr. Caplan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls Costical Fel (110). I 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 (Premarket Approval), it may be subject to such additional controls. Existing major (1 remations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify tuch assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Jay Caplan

This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow you to ocgan mainenses of your device 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 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]. ad vertibing or your a regulation entitled, "Misbranding by reference to premarket Also, picase note the regulation only and information on your responsibilities under the nothloudon' (21 OF IC 0017) vision of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Donna R. Lochner -

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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# 510(k) Number (if known): K994260

Device Name: Candela (Modified) GentleLASE GL Dermatology Laser

Indications For Use:

The Candela GentleLASE GL Dermatology Laser is indicated for the following uses :

- The Photocoagulation of Dermatological vascular lesions. 1.
- Temporary hair reduction. 2.
- Stable long-term, or permanent hair reduction through 3 . selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. It is also intended for the photocoagulation of dermatological vascular lesions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dune R. Lochner.

(Division Sign-Off) Invision Sign-O1-O1-O1-( 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional format 1-2-96)