CANDELA GENTLELASE II DERMATOLOGICAL LASER

K984601 · Candela Corp. · GEX · Feb 4, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K984601
• Device Name: CANDELA GENTLELASE II DERMATOLOGICAL LASER
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the laser system is for the Photocoagulation of Dermatological vascular lesions and for hair removal. The Candela GentleLase II Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for: 1. the reduction of pain. 2. cooling of skin prior to laser treatment.

Device Story

Candela GentleLase II is a long-pulse Alexandrite laser system emitting 755 nm near-infrared energy. System components include high-voltage power supply, optical laser head, circulator, optical delivery system (fiber/handpiece), software control, and Dynamic Cooling Device (DCD). Operated by clinicians in a dermatology setting via an onboard control panel. Laser energy targets vascular lesions or hair follicles; DCD provides cryogen cooling to skin surface prior to laser pulse to minimize thermal damage and reduce pain. Safety interlocks protect patients and operators. Output is pulsed laser energy; clinical benefit includes effective hair removal and vascular lesion treatment with reduced thermal injury and pain.

Clinical Evidence

No clinical data provided in the summary; substantial equivalence is supported by bench testing, including conformance to Laser Performance Standard (21 CFR 1040), UL 544 electrical safety standards, and EU Medical Device Directives.

Technological Characteristics

Alexandrite crystal laser source; 755 nm wavelength; pulsed energy delivery via optical fiber/handpiece. Includes integrated Dynamic Cooling Device. Safety interlocks included. Conforms to 21 CFR 1040 and UL 544 standards.

Indications for Use

Indicated for photocoagulation of dermatological vascular lesions and hair removal. Includes integrated Dynamic Cooling Device for pain reduction and skin cooling prior to laser treatment.

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 (K981351, K972767, K974381)
• Sharplan EpiTouch Alex Laser (K973354)
• Cynosure Apogee 40 Laser (K971737)

Submission Summary (Full Text)

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FEB 4 1939

## 510(k) Summary

### General Information:

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

| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in General<br>and Plastic Surgery and in Dermatology) |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Dermatology Laser, Long pulse Alexandrite Laser |
| Predicate Devices: | Candela GentleLase GL laser cleared under 510(k)s K981351, K972767<br>and K974381, Sharplan EpiTouch Alex Laser cleared under 510(k)<br>K973354 and the Cynosure Apogee 40 Laser cleared under 510(k)<br>notification number K971737 |

#### Description:

The Candela GentleLase II 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 II Laser is designed with six major components:

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

The Candela GentleLase II Laser is 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 use of the laser system is for the Photocoagulation of Dermatological vascular lesions and for hair removal.

#### Testing:

As a laser product, the GentleLase II is required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition the device conforms to the UL 544 electrical safety standard and the Essential Requirements of the European Union Medical Device Directives.

#### Summary of Substantial Equivalence:

The Candela GentleLase II 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 II Laser System is substantially equivalent to the predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

FEB 4 1559 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K984601

Trade Name: Candela GentleLase II Dermatology Laser Regulatory Class: II Product Code: GEX Dated: December 24, 1998 Received: December 28, 1998

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 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 (Premarket Approval), 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 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 such 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) 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division 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 vours.

Styph Plurdic

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

K984601

Device Name: Candela GentleLase II Dermatology Laser

Indications For Use:

The Candela GentleLase II Dermatology Laser is indicated for the following uses :

1. the photocoagulation of dermatological vascular lesions.

2. the removal of hair.

The Candela GentleLase II Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for:

1. the reduction of pain.

2. cooling of skin prior to laser treatment.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Hypt Plevels

(Division Sign-Off)

Division of General Restorative Devices <984601 510(k) Number

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional format 1-2-96)

079