CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG

K022951 · Candela Corp. · GEX · Jan 27, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K022951
• Device Name: CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 27, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GentleYAG Laser is intended for use in the treatment of facial wrinkles.

Device Story

GentleYAG Laser System is a dermatology laser used for facial wrinkle treatment. System components include a laser console with control electronics/software, control/display panel, lens-coupled optical fiber handpiece, integrated skin cooling device, footswitch/handswitch, and remote interlock connector. Operated by clinicians in a professional setting. Device delivers laser energy to skin; integrated cooling protects skin surface during treatment. Output allows clinicians to perform dermatological procedures aimed at wrinkle reduction. Benefits include non-invasive treatment of facial wrinkles.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Laser surgical instrument (Class II, 21 CFR 878.4810). System includes laser console, control electronics, optical fiber handpiece, and integrated skin cooling. Operates as a laser surgical instrument. Connectivity includes remote interlock. Software is embedded for system control.

Indications for Use

Indicated for the treatment of facial wrinkles.

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 Long Pulse Nd:Yag Laser (K010104)
• Lyra Surgical Laser System (K020021)

Submission Summary (Full Text)

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ELA

I. General Information

KO22951

JAN 2 7 2003

## 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) Summary of Safety and Effectiveness for the Candela GentleYAG Laser System is being submitted in accordance with the requirements of the SMDA 1990, 21 CFR 807.92 and follows the guidance concerning the organization and content of a 510(k) summary.

| Applicant: | Candela Corporation |
|------------------------|------------------------------------------------------------------------------------------------------------------------|
| Address: | 530 Boston Post Road<br>Wayland, MA 01778-1886 |
| Contact Person: | Lorraine Nelson<br>Manager, Regulatory Affairs |
| Date Prepared: | August 27, 2002 |
| II. Names | |
| Device Trade Name: | GentleYAG Laser System |
| Common Name | Dermatology Laser |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument<br>for use in General and Plastic Surgery and in<br>Dermatology) |
| III. Predicate Devices | |
| | Candela Long Pulse Nd:Yag Laser (K010104)<br>Lyra Surgical Laser System (K020021) |

## IV. Product Description

The GentleY AG laser consists of the following main components:

- a laser system console (including software and control electronics) ●
- . a control and display panel
- a lens-coupled, user replacement optical fiber handpiece ●
- a skin cooling device integrated into the handpiece .
- a footswitch or handswitch
- . a remote interlock connector

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#### V. Intended Use

- The GentleYAG Laser is intended for use in the treatment of facial wrinkles. ●
## VI. Rationale for Substantial Equivalence

The Candela GentleY AG Laser shares the same indications for use, matches key design aspects, including spot size, similar wavelength and/or the same maximum delivered power as the predicate devices, and therefore are substantially equivalent to the currently marketed Candela Long Pulse Nd: YAG Laser System (K010104) and the Laserscope Lyra Surgical Laser System (K020021).

#### VII. Safety and Effectiveness Information

The new indications for use are based on the indications for use for the predicate laser svstems.

Technologically, the Candela GentleYAG Laser is identical to the previous predicate Candela Long Pulse Nd: YAG Laser (K010104), and the Laserscope Lyra Surgical Laser System (K02002) therefore the risks and benefits for the GentleY AG Laser are comparable to these predicate device (s).

We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the device.

## VIII. Conclusion

It is the opinion of Candela Corporation that the GentleY AG Laser System is substantially equivalent to the predicate devices based on operating principles, materials, mechanism of action, design, construction, methods of assembly and intended uses.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them. The logo is black and white.

Public Health Service

JAN 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Candela Corporation William H. McGrail Vice President, Research & Development & Operations 530 Boston Post Road Wayland, Massachusetts 01778

Re: K022951 Trade/Device Name: Gentle YAG Laser Syster Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic Surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: December 16, 2002 Received: December 17, 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 no: 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

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Page 2 - Mr. William H. McGrail

(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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). 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,

Miriam C. Provost
for

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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Image /page/4/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame icon on the left and the word "CANDELA" on the right. The flame icon is black and white and has a modern, geometric design. The word "CANDELA" is written in a simple, sans-serif font.

# INDICATION FOR USE STATEMENT

510(k) Number (if known): ヒロ2299

Device Name:

Candela Corporation Gentle Y AG Laser System

Indication For Use:

The Candela GentleYAG Laser System is intended for the treatment of facial wrinkles.

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C Provost

Vision Sign-Off ivision of General, Restorative ad Neurological Devices

K022951

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_________