FRAXEL SR LASER SYSTEM

K050841 · Reliant Technologies, Inc. · GEX · Jul 5, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050841
• Device Name: FRAXEL SR LASER SYSTEM
• Applicant: Reliant Technologies, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reliant Laser System II is intended for use in: Dermatological procedures requiring the coagulation of soft tissue; Treatment of periorbital wrinkles; 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 uses fiber lasers to deliver thermal energy to epidermis and upper dermis; system utilizes scanning and focusing optics to create specific energy patterns. Device operated by clinicians in dermatology settings. Embedded processor controls laser delivery. Output consists of controlled thermal coagulation for skin resurfacing and lesion treatment. Benefits include non-invasive tissue coagulation and wrinkle reduction. System conforms to 21 CFR 1040 laser safety standards.

Clinical Evidence

Clinical performance demonstrated via peer-reviewed publications and clinical investigations. Data confirmed the device performs as intended for dermatological applications without introducing new safety or effectiveness issues.

Technological Characteristics

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

Indications for Use

Indicated for patients requiring dermatological soft tissue coagulation, treatment of periorbital wrinkles, 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 (K043219)
• Palomar Starlux (K033549)
• Sciton BBL System (K032460)

Submission Summary (Full Text)

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JUL 5 - 2005

Reliant Technologies, Inc.

### 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. Laser System, as well as the substantial equivalence decision making process.

| Submitter: | Reliant Technologies, Inc. |
|-------------------------------------|-----------------------------------------------------|
| Address: | 260 Sheridan Ave., Suite 300<br>Palo Alto, CA 94306 |
| Contact Person: | Heather Tanner<br>Clinical and Regulatory Affairs |
| Telephone: | [phone] ext. 103 |
| Facsimile: | [phone] |
| Date prepared: | March 31, 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 K043219 Palomar Starlux K033549 Sciton BBL System K032460

#### 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;

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

Skin resurfacing procedures.

# 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.

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### 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

Results of peer-reviewed publications and clinical investigations were used to demonstrate that the Fraxel SR Laser System functioned as clinically intended. Sufficient data have been gathered from clinical studies to determine that the Fraxel SR Laser System performs as clinically intended and that no new issues of safety and effectiveness are introduced.

### Conclusion

ત્વની સ

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 5 - 2005

Ms. Heather Tanner Clinical and Regulatory Affairs Reliant Technologies Incorporated 260 Sheridan Avenue, Suite 300 Palo Alto, California 94306

Re: K050841

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: March 31, 2005 Received: April 14, 2005

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 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.

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Page 2 - Ms. Heather Tanner

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 Sovall 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.

Eue A. Mann, M

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number:

150841

Device Name:

Reliant Laser System II and Accessories (Fraxel SR Laser System)

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;

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

Skin resurfacing procedures."

. * .

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

or

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ ﺳﮯ (Per 21 CFR 801 Subpart D)

Over-The-Counter Use (Per 21 CFR 801 Subpart C)

Division Sign-off Division of General, Restorative and Neurological Devices

510(k) Number

Signature

101 Sign-Off) vision of General, Restorative 1d Neurological Devices

KOS0841