FRAXEL SR LASER SYSTEM

K053047 · Reliant Technologies, Inc. · GEX · Mar 20, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053047
• Device Name: FRAXEL SR LASER SYSTEM
• Applicant: Reliant Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 20, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reliant Laser System II and accessories (Fraxel SR Laser System) is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Treatment of surgical scars and acne scars; Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia; Skin resurfacing procedures.

Device Story

Fraxel SR Laser System is a dermatology laser device; utilizes fiber lasers with scanning and focusing optics to deliver thermal energy patterns to epidermis and upper dermis. Operated by clinicians in a professional setting; device includes tip attachments. Embedded processor controls laser delivery. Output is thermal energy for coagulation and resurfacing; intended to improve skin appearance and treat scars/lesions. Clinical benefit includes non-invasive skin resurfacing and lesion treatment.

Clinical Evidence

Clinical performance data was used to demonstrate that the Fraxel SR Laser System functioned as clinically intended and that no new issues of safety and effectiveness are introduced.

Technological Characteristics

Fiber laser system; scanning and focusing optics; embedded processor control; tip attachments; conforms to 21 CFR 1040.

Indications for Use

Indicated for dermatological procedures requiring soft tissue coagulation, treatment of periorbital wrinkles, surgical and acne scars, photocoagulation of pigmented lesions (e.g., lentigos, melasma, dyschromia), and skin resurfacing.

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

• Fraxel SR Laser System (K050841)
• Candela VBeam (K033461)
• Candela CBcam (K033331)
• Candela Smoothbeam (K041242)
• CoolTouch CT3 (K043046)
• Lumenis Ultrapulse Encore (K022060)

Submission Summary (Full Text)

{0}------------------------------------------------

# Kos 3047

:

# APPENDIX A 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

A - l

{1}------------------------------------------------

# <05 7047

## 510(k) SUMMARY

As required by Section 12 of the Medical Devices Act of 1990, Reliant technologies, Inc. is providing a summary of safety and effectiveness information available for Reliant Technologies, Inc. Is provincing a as well as the substantial equivalence decision making process.

| Submitter: | Reliant Technologies, Inc. |
|----------------------|---------------------------------------------------|
| Address: | 464 Ellis St.<br>Mountain View, CA 94043 |
| Contact Person: | Heather Tanner<br>Clinical and Regulatory Affairs |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date prepared: | October 27, 2005 |
| Device Trade Name: | Fraxel SR Laser System |
| Common Name: | Dermatology Laser |
| Classification Name: | Laser Surgical Instrument<br>21 C.F.R § 878.4810 |

Legally Marketed Predicate Devices:

Fraxel SR Laser System K050841 Candela VBeam K033461 Candela CBcam K033331 Candela Smoothbeam K041242 CoolTouch CT3 K043046 Lumenis Ultrapulse Encore K022060

#### Description of the Fraxel SR Laser System

The Fraxel SR Laser System consists of a set of fiber lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a pattern of thermal energy to the epidermis and upper dermis. Device accessories include tip attachments.

#### Indications for Use

The Reliant Laser System II is intended for use in:

Dermatological procedures requiring the coagulation of soft tissue;

Treatment of periorbital wrinkles;

Treatment of surgical scars and acne scars;

Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;

Skin resurfacing procedures.

{2}------------------------------------------------

## Compliance to 21 CRF 1040

As a laser product, the Fraxel SR Laser System is required to conform and does conform to the requirements of 21 CFR 1040.

### Substantial Equivalence Comparison

The technological characteristics and indications for use of the Fraxel SR Laser System are similar to those of the cited predicate laser devices. These devices are equivalent in terms of design, materials, principal of operation, and product specifications. Any differences between the Reliant Technologies Laser System II and the predicate devices do not raise new issues regarding safety or effectiveness.

## Clinical Performance Data

Clinical performance data was used to demonstrate that the Fraxel SR Laser System functioned as clinically intended. The results from clinical investigation allowed for the determination that the Fraxel SR Laser System performs as clinically intended and that no new issues of safety and effectiveness are introduced.

#### Conclusion

Based on the design, materials, function, intended use, and clinical evaluation, the Fraxel SR Laser System is substantially equivalent to the devices currently marketed under the Federal Food, Druscand Cosmetic Act. In addition, the Fraxel SR Laser System raises no new safety or effectiveness issues. Therefore, safety and effectiveness are reasonably assured, justifying 510(k) of earcon for commercial sale.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle image. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2006

Reliant Technologies, Inc. c/o Ms. Heather Tanner Clinical Research/Regulatory Affairs Manager 464 Ellis Street Mountain View, California 94043

Re: K053047

Trade/Device Name: Reliant Laser System II and accessories (Fraxel SR Laser System) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 16, 2006 Received: February 17, 2006

Dear Ms. Tanner:

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

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

#### Page 2 - Ms. Heather Tanner

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 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 vours.

emde

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known): K053047

Device Name:

Indications For Use:

"The Reliant Laser System II and accessories (Fraxel SR Laser System) is intended for use in:

Dermatological procedures requiring the coagulation of soft tissue;

Treatment of periorbital wrinkles;

Treatment of surgical scars and acne scars;

Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma and dyschromia;

Skin resurfacing procedures."

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

.gride

Division of General. Restorative. and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________