CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER

K972767 · Candela Corp. · GEX · Dec 4, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K972767
• Device Name: CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Candela Gentlelase GL Dermatology Vascular Lesion Laser is used for the photocoagulation of dermatological vascular lesions.

Device Story

Candela Gentlelase GL is a long-pulse Alexandrite laser system; emits pulsed energy at 755 nm (near-infrared). System components: high voltage power supply/modulator, optical laser head, circulator system, and optical fiber/handpiece delivery system. Used in clinical settings by trained operators to treat dermatological vascular lesions via photocoagulation. Operator selects parameters via onboard control panel; safety interlocks protect patients and users. Laser energy delivered to target area via handpiece; thermal effect achieves photocoagulation of vascular lesions.

Clinical Evidence

Bench testing only; consists of component testing and functional testing of the completed laser system.

Technological Characteristics

Alexandrite rod (crystal) laser source; 755 nm wavelength; near-infrared emission. High voltage power supply, modulator, circulator, and optical fiber/handpiece delivery system. Onboard control panel for parameter selection. Safety interlock systems included. Class II device (21 CFR 878.4810).

Indications for Use

Indicated for the photocoagulation of dermatological vascular lesions. Prescription use only.

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

• Cynosure Photogenica LP Laser (K963094)

Reference Devices

• Candela Q-Switched Alexandrite Lasers

Submission Summary (Full Text)

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K972767

DEC - 4 1997

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.

| 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, Longpulse Alexandrite Laser |
| Predicate Device: | Cynosure Photogenica LP Laser cleared on 10/29/96 under 510(k)<br>notification number K963094 |

### Description:

The Candela Gentlelase GL Lasers utilize 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 Candela Gentlelase Lasers are designed with four major components:

- 1. High voltage power supply and modulator system
- 2. Optical laser head
- 3. Circulator system
- 4. Optical delivery system

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 use of the device is for the photocoagulation of dermatological vascular lesions.

#### Testing:

Testing of the GentleLase Laser consists of component testing and functional testing of the completed Laser.

# 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 device.

On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela believes that its Candela Gentlelase lasers are substantially equivalent to previously cleared Candela Q-Switched Alexandrite Lasers and in similarity of intended use and in performance specification equivalent to the Cynosure Photogenica LP Laser.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping to suggest a sense of community and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

DEC - 4 1997

Re: K972767

> Trade Name: Candela GentleLase GL Dermatological Vascular Lesion Laser Regulatory Class: II Product Code: GEX Dated: October 15, 1997 Received: October 16, 1997

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 requirements , 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

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Page 2 - Mr. Caplan

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.

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 yours.

tballa

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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K972767

DEC - 4 1997

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.

| 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, Longpulse Alexandrite Laser |
| Predicate Device: | Cynosure Photogenica LP Laser cleared on 10/29/96 under 510(k)<br>notification number K963094 |

### Description:

The Candela Gentlelase GL Lasers utilize 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 Candela Gentlelase Lasers are designed with four major components:

- 1. High voltage power supply and modulator system
- 2. Optical laser head
- 3. Circulator system
- 4. Optical delivery system

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 use of the device is for the photocoagulation of dermatological vascular lesions.

#### Testing:

Testing of the GentleLase Laser consists of component testing and functional testing of the completed Laser.

# 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 device.

On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela believes that its Candela Gentlelase lasers are substantially equivalent to previously cleared Candela Q-Switched Alexandrite Lasers and in similarity of intended use and in performance specification equivalent to the Cynosure Photogenica LP Laser.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

DEC - 4 1997

Re: K972767

> Trade Name: Candela GentleLase GL Dermatological Vascular Lesion Laser Regulatory Class: II Product Code: GEX Dated: October 15, 1997 Received: October 16, 1997

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 requirements , 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

{5}------------------------------------------------

Page 2 - Mr. Caplan

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.

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 yours.

tballa

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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K972 j10(k) Number (if known):

Device Name: Candela GentleLase GL Dermatology Vascular Lesion Laser

Indications For Use:

The Candela Gentlelase GL Dermatology Vascular Lesion Laser is used 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)

Evaluation (SDE)

Division of General Restorative Devices
510(k) Number: 272767

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional format 1-2-96)

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