CANDELA GENTLELASE FAMILY OF LASER SYSTEMS

K024260 · Candela Corp. · GEX · Mar 21, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024260
• Device Name: CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Temporary hair reduction. 2. 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. 3. On all skin types (Fitzpatrick I-VI) including tanned skin.

Device Story

The Candela GentleLASE Family of Laser Systems is a dermatology laser used by clinicians for hair reduction. The device utilizes an Alexandrite crystal rod to emit pulsed 755 nm near-infrared laser energy. Energy is delivered to the skin via an optical fiber and handpiece, producing circular beams (6-18 mm diameters). A Dynamic Cooling Device (DCD) sprays cryogen onto the skin immediately before the laser pulse to protect the epidermis. The system includes a high-voltage power supply, optical laser head, circulator, delivery system, software control, and DCD. Operators select parameters via an onboard control panel. The laser targets melanin in hair follicles to achieve hair reduction. Safety interlocks are integrated to protect patients and operators.

Clinical Evidence

Bench testing only. The device conforms to the Laser Performance Standard (21 CFR 1040), UL 2601 Electrical Safety Standard, and EN 60601-1-2.

Technological Characteristics

Alexandrite crystal laser; 755 nm wavelength; pulsed energy delivery. Optical fiber/handpiece delivery system with 6, 8, 10, 12, 15, 18 mm spot sizes. Integrated Dynamic Cooling Device (cryogen spray). Safety interlocks. Electrical safety per UL 2601 and EN 60601-1-2. Laser performance per 21 CFR 1040.

Indications for Use

Indicated for temporary or permanent hair reduction in patients of all skin types (Fitzpatrick I-VI), including tanned skin, 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 (K994260)

Submission Summary (Full Text)

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K 024260

#### General Information:

This 510(k) is to provide notification of substantial equivalence for the Candela Gentle. ASE Family of Laser Systems, which is substantially equivalent to previously marketed devices intended for temporary hair reduction. 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. The GentleLASE Family of lasers are indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin.

| Submitted by: | Candela Corporation<br>530 Boston Post Road<br>Wayland, MA 01778-1886 |
|--------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | William H. McGrail |
| Date prepared: | December 19, 2002 |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in<br>General and Plastic Surgery and in Dermatology) |
| Common Name: | Dermatology Laser, GentleLASE Family of Laser Systems |
| Predicate Devices: | Candela GentleLASE GL (K994260) |

#### Description:

The Candela GentleLASE Family of Lasers 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 target area via optical fiber/handpiece delivery system. The Dynamic Cooling Device, which provides a short burst of cryogen spray prior to firing the laser pulse. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 6, 8, 10, 12, 15, 18 millimeters on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece. The GentleLASE Family of Laser Systems are designed with six major components:

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

The Candela GentleLASE Family of Laser Systems 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.

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### Testing:

As laser products, the GentleLASE Family of laser Systems are required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition the GentleLASE Family of Laser Systems conforms to the UL 2601 Electrical Safety Standard and with the Harmonized Standard EN 60601-1-2, Part 2 established by and required by the European Community.

### Summary of Substantial Equivalence:

The Candela GentleLASE Family of Laser Systems have the same intended use, utilizes similar operating principles and matches key design aspects, including similar spot size, the same wavelength and the same maximum delivered fluence as the predicate device.

On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela Corporation believes that the Candela GentleLASE Family of Laser Systems are substantially equivalent to the predicate device.

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Public Health Service

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MAR 21 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. William H. McGrail Vice President of Research & Development and Operations Candela Corporation 530 Boston Post Road Wayland, MA 01778

Re: K024260 Trade/Device Name: Candela GentleLASE Family of Laser Systems Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for us in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 20, 2002 Received: December 23, 2002

Dear Mr. McGrail:

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

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# Page 2 - Mr. William H. McGrail

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. 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]. 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 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

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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# INDICATION FOR USE STATEMENT

KO24260 5 10(k) Number (if known):

Candela GentleLASE Family of Laser Systems Device Names

Indications For Use:

- 1. Temporary hair reduction.
- 2. 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.
- 3. On all skin types (Fitzpatrick I-VI) including tanned skin.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

urianne C. Phrost

f General, Restorative and Neurological Devices

510(k) Numb

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