FRAXEL II SR LASER SYSTEM

K062303 · Reliant Technologies, Inc. · GEX · Jan 31, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K062303
• Device Name: FRAXEL II SR LASER SYSTEM
• Applicant: Reliant Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fraxel II SR Laser System and accessories is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; Treatment of acne scars and surgical 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

The Fraxel II SR Laser System is a dermatological laser device used by clinicians for soft tissue coagulation and skin resurfacing. It utilizes a set of fiber lasers to deliver thermal energy to the epidermis and dermis. The system incorporates scanning and focusing optics to create specific energy patterns on the skin. An embedded processor controls the laser delivery. The device is used in clinical settings for the treatment of wrinkles, scars, and pigmented lesions. By inducing controlled thermal injury, the device facilitates skin resurfacing and tissue coagulation, potentially improving skin texture and appearance. The clinician operates the system, using accessories such as tip kits and pre-treatment solutions to manage the procedure.

Clinical Evidence

Clinical performance supported by Non-Significant Risk and IDE studies. Data indicates the device performs as intended for dermatological applications with no new safety or effectiveness issues identified.

Technological Characteristics

Fiber laser system; scanning and focusing optics for thermal energy delivery; embedded processor control. Class II laser surgical instrument. No changes to laser wavelength or operating principle compared to predicates.

Indications for Use

Indicated for dermatological procedures requiring soft tissue coagulation, treatment of periorbital wrinkles, acne scars, surgical scars, photocoagulation of pigmented lesions (lentigos, sun spots, 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 II SR Laser System and Accessories (K060310)
• Fraxel SR Laser System and Accessories (K050841)
• Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories (K022060)

Submission Summary (Full Text)

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#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

# COMPANY NAME/CONTACT

Heather Tanner Reliant Technologies, Inc. 464 Ellis St. Mountain View, CA 94043 650 641-5861 650 641-3461 fax [e-mail]

JAN 3 1 2007

#### NAME OF DEVICE

Trade Name: Common Name: Regulation Number Product code: Device Panel: Device Classification: Fraxel II SR Laser System and Accessories Laser Surgical Instrument 878.4810 GEX General Surgery/Restorative Devices Class II

### LEGALLY MARKETED PREDICATE DEVICES

Name: Fraxel II SR Laser System and Accessories 510(k) #: K060310

Name: Fraxel SR Laser System and Accessories 510(k) #: K050841

Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #: K022060

# DEVICE DESCRIPTION

The Fraxel II 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 dermis. Device accessories include tip kits and pre-treatment solution.

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062303

# INDICATION FOR USE STATEMENT

The Fraxel II SR Laser System is intended for use in:

Dermatological procedures requiring the coagulation of soft tissue;

Treatment of periorbital wrinkles:

Treatment of acne scars and surgical scars;

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

Skin resurfacing procedures.

### SUBSTANTIAL EQUIVALENCE COMPARISON

#### Indications for Use

Substantial equivalence for the Fraxel II SR Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indication statements.

#### Clinical Performance Data

Clinical analysis was conducted on Non-Significant Risk and IDE Reliant studies to support the clinical performance of the Fraxel II SR Laser System. Sufficient safety data has been gathered to determine that the Fraxel II Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced.

#### Technological Characteristics

Key technological characteristics of the Fraxel II SR Laser System, such as energy type and operating principle, are equivalent to the Fraxel II SR Laser System as described in submission K060310 and the Fraxel SR Laser System as described in submission K053047.

#### CONCLUSION

Based on the design, materials, function, intended use and clinical evaluation, the Fraxel II Laser System and Accessories is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. No changes are being made in the laser wavelength or operating principle. Safety and effectiveness are reasonably assured, justifying 510(k) clearance.

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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 a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Reliant Technologies % Ms. Heather MacFalls 464 Ellis Street Mountain View, California 94043

JAN 3 1 2007

#### Re: K062303

Trade/Device Name: Fraxel II SR Laser System and Accessories Regulation Number: 21 CFR 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: January 5, 2007 Received: January 5, 2007

Dear Ms. MacFalls:

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, TDA max 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the sectoric product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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/industry/support/index.html.

Sincerely yours,

Mark N. Malkerson

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

Enclosures

cc: HFZ-401 DMC FZ-404 510(k) Staff

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# Indications for Use

510(k) Number (if known): ├об2 30 3

Device Name: Fraxel II SR Laser System and accessories Indications For Use:

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

Dermatological procedures requiring the coagulation of soft tissue;

Treatment of periorbital wrinkles;

Treatment of acne scars and surgical 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)

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Division of General, Restorative and Neurological Devices

510(k) Number_`K00302