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

This 510(k) summary describes a Fraxel III SR Laser System (Fraxel re:pair™) for dermatological procedures. It doesn't contain information about a study with acceptance criteria and a reported device performance table as would be typical for an AI/ML device submission. Instead, it relies on substantial equivalence to predicate devices and clinical data from non-significant risk and investigational device exemption studies to support its safety and effectiveness.

Here's an analysis of the provided text in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. This submission is for a medical device (laser system), not an AI/ML diagnostic or predictive tool, and thus the structure of its performance evaluation is different. Performance is asserted based on clinical intent and no new safety/effectiveness issues, rather than statistical metrics against specific acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

This information is not explicitly provided. The document states:
"Non-Significant Risk and Investigational Device Exemption studies support the clinical performance of the Fraxel III SR (Fraxel re:pair) Laser System."
"Sufficient clinical data supported the determination of safety and effectiveness for the Fraxel III SR (Fraxel re:pair) Laser System and Accessories."

Without access to the actual study reports, details on sample sizes, patient demographics, data provenance (e.g., country of origin, retrospective/prospective nature), or specific evaluation methodologies for these underlying clinical studies are unavailable in this 510(k) summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided. The assessment relies on the overall clinical performance demonstrated in the aforementioned studies, but the role of experts for "ground truth" as you'd define it for an AI model is not detailed here. The clinical evaluation implicitly involves medical professionals, but their specific role in establishing "ground truth" for a test set is not described.

4. Adjudication Method for the Test Set

This information is not provided. As this is not an AI/ML submission where a ground truth is established for a test set through human review, an adjudication method for such a test set is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

A MRMC comparative effectiveness study is not mentioned. This type of study is more relevant for AI/ML diagnostic tools where the impact of AI assistance on human readers is being evaluated. This submission is for a therapeutic laser device.

6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done

A standalone performance study is not applicable and therefore not mentioned. This device is a laser system; its "performance" is inherently tied to its application by a trained medical professional. It does not operate as an algorithm independently.

7. The Type of Ground Truth Used

The concept of "ground truth" as applied to AI/ML models is not directly applicable or discussed in this document. The "ground truth" for a therapeutic device's effectiveness would be clinical outcomes observed in patients (e.g., reduction in wrinkles, successful soft tissue ablation), as determined by medical professionals in the clinical studies. The summary states that "The device performed as clinically intended with no new issues of safety and effectiveness introduced."

8. The Sample Size for the Training Set

This information is not provided. The concept of a "training set" in the context of machine learning is not relevant to this submission, which is for a hardware device (laser system). The "training" here would refer to the engineering and development of the laser itself and clinical trials involving patients.

9. How the Ground Truth for the Training Set Was Established

This information is not provided. Again, the concept of "ground truth for a training set" as used for AI/ML models is not directly applicable to a therapeutic laser device. The "ground truth" in device development relates to engineering specifications and clinical efficacy/safety observed in product development and clinical trials.

Summary

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07105

NOV = 2 2007

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT

Heather MacFalls Reliant Technologies, Inc. 464 Ellis St. Mountain View, CA 94043 650 605-2257 650 605-2057 fax hmacfalls@fraxel.com

NAME OF DEVICE

Trade Name:

Common Name: Regulation Number Product code: Device Panel: Device Classification: Fraxel III SR Laser System (Fraxel re:pair™) 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: Fraxel II SR Laser System and Accessories 510(k) #: K062303

Name: Fraxel III SR Lascr System and Accessories 510(k) #: K063038

Name: Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories 510(k) #: K022060, K030147

DEVICE DESCRIPTION

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0710j1

INDICATION FOR USE STATEMENT

The Fraxel III SR (Fraxel re:pair™) Laser System is intended for use in:

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

Treatment of wrinkles, rhytides, furrows, fine lines, texture irregularities, pigmented lesions and vascular dyschromia.

SUBSTANTIAL EQUIVALENCE COMPARISON

Indications for Use

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

Clinical Performance Data

Non-Significant Risk and Investigational Device Exemption studies support the clinical performance of the Fraxel III SR (Fraxel re:pair) Laser System. Sufficient clinical data supported the determination of safety and effectiveness for the Fraxel III SR (Fraxel re:pair) Laser System and Accessories. The device performed as clinically intended with no new issues of safety and effectiveness introduced.

Technological Characteristics

Key technological characteristics of the Fraxel III SR (Fraxel re:pair) 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, to the Fraxel II SR Laser System as described in K062303 and to the Lumenis Ultrapulse Encore Laser System as described in K020660 and K030147.

CONCLUSION

Based on the design, materials, function, intended use and clinical evaluation, the Fraxel III (Fraxel re:pair) 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a graphic representation of a human figure, with three abstract shapes forming the head, body, and legs. The logo is simple and recognizable, representing the department's focus on health and human well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 2 2007

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

Re: K071051

Trade/Device Name: Fraxel III SR Laser System (Fraxel re:pair™) 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: II Product Code: GEX Dated: August 1, 2007 Received: August 7, 2007

Dear Ms. MacFalls:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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Page 2 - Ms. Heather MacFalls

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) 276-0120. 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,

For Off- Oct 06
li.17

Mark N. Melkerson 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):

Fraxel III SR Laser System (Fraxel re:pair™) and Accessories Device Name: Indications For Use:

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

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

Treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia."

Prescription Use X (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)

No
Division Si

Division Sign-Of Division of General, Restorative age 1 of 1 and Neurological Devices

510(k) Number `co7105

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.