The Fraxel III SR Laser System consists of a laser source which delivers a pattern of thermal energy to the epidermis and dermis using scanning and focusing optics. Device accessories include interchangeable treatment tips.

AI/ML Overview

The provided text describes the 510(k) summary for the Fraxel III SR Laser System. However, it does not contain the specific details required to complete your request regarding acceptance criteria and a detailed study.

The document states:

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

This indicates that clinical studies were performed, and favorable safety data was collected, but the specific metrics, acceptance criteria, sample sizes, expert details, or study methodology (e.g., MRMC, standalone) are not provided in this summary.

Therefore, I cannot fill out the detailed tables and information sections you requested based solely on the provided text. The document focuses on regulatory approval based on "substantial equivalence" to predicate devices rather than a detailed report of a specific clinical trial's performance metrics against predefined acceptance criteria.

Summary

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K 063038

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

APR 2 7 2007

COMPANY NAME/CONTACT

Heather Tanner MacFalls Reliant Technologies, Inc. 464 Ellis St. Mountain View, CA 94043 650 641-5861 650 641-3461 fax hmacfalls@reliant-tech.com

NAME OF DEVICE

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

LEGALLY MARKETED PREDICATE DEVICES

Name: Fraxel SR Laser System and Accessories 510(k) #: K053047, K050841, K042319, K040617 and K031795

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

DEVICE DESCRIPTION

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K06303P

INDICATION FOR USE STATEMENT

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

Dermatological procedures requiring ablation (removal), coagulation and resurfacing of soft tissue.

SUBSTANTIAL EQUIVALENCE COMPARISON

Indications for Use

Substantial equivalence for the Fraxel III 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 Investigational Device Exemption studies to support the clinical performance of the Fraxel III SR Laser System. Sufficient safety data has been gathered to determine that the Fraxel III 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 III SR Laser System, such as energy type and operating principle, are equivalent to the Fraxel SR Laser System as described in submissions K053047, K050841, K042319, K040617 and K031795 and to the Lumenis Ultrapulse Encore Laser System as described in K020660.

CONCLUSION

Based on the design, materials, function, intended use and clinical evaluation, the Fraxel III Laser System and Accessories is substantially equivalent to the devices currently marketed under the Federal Food, Drug and Cosmetic Act. Safety and effectiveness are reasonably assured, justifying 510(k) clearance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Reliant Technologies, Inc. % Reliant Technologies, Inc. Ms. Heather Tanner MacFalls Director of Regulatory and Clinical Affairs 464 Ellis Street Mountain View, California 94043

APR 2 7 2007

Re: K063038 Trade/Device Name: Fraxel III 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: February 27, 2007 Received: March 1, 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, 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

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Page 2 - Ms. Heather Tanner MacFalls

quality systems (OS) 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sincerely yours,

for

Mark N. Melkerson

Mark N. Melke 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 (if known):

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

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

Dermatological procedures requiring ablation (removal), coagulation and resurfacing of soft tissue.

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)

(Division Sign Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of __
*19 (K) Number 1063088

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.