The Fraxel® SR 1500 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 for treatment of dyschromia and pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis and melasma; Skin resurfacing procedures.

Device Description

The Fraxel® SR1500 Laser System consists of a fiber laser, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics to deliver a controlled pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.

AI/ML Overview

The provided 510(k) summary for the Fraxel® SR1500 Laser System and Accessories does not contain information about acceptance criteria or a study proving its performance against such criteria in the manner typically expected for diagnostic AI/ML devices.

Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices based on identical or similar indications for use and technological characteristics. This type of submission relies on the prior clearance of the predicate devices and argues that the new device does not introduce new issues of safety or effectiveness.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement are not applicable or not provided in this specific 510(k) document.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not Provided. The document does not specify quantitative acceptance criteria or report performance metrics (e.g., sensitivity, specificity, accuracy, dice score, etc.) for the device. The "performance" mentioned refers to the device performing as clinically intended, which is a qualitative statement based on comparison to predicate devices, not specific metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Provided. This type of information is typically found in clinical studies, which are not detailed in this 510(k) summary for establishing performance against criteria. The "clinical performance data" mentioned is not described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Provided. Since no specific test set or ground truth establishment process is described, information about experts is absent.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Provided. As no test set is detailed, no adjudication method is mentioned.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable / Not Provided. The Fraxel® SR1500 Laser System is a physical laser device for dermatological procedures, not an AI/ML diagnostic or image interpretation tool designed to assist human readers. Therefore, an MRMC study related to human reader improvement with AI assistance would not be relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable / Not Provided. This device is a laser system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Provided. No ground truth is described as the 510(k) focuses on substantial equivalence to predicate devices, not novel performance claims requiring new clinical validation data.

8. The sample size for the training set

Not Applicable / Not Provided. This device is a laser system, generally not trained in the same way an AI/ML algorithm would be. The device itself is "controlled by an embedded processor" but the submission doesn't describe any machine learning training.

9. How the ground truth for the training set was established

Not Applicable / Not Provided. See point 8.

Summary based on the Provided Text:

The 510(k) submission for the Fraxel® SR1500 Laser System and Accessories does not describe specific acceptance criteria or an analytical/clinical study to demonstrate performance against such criteria. Instead, it relies on demonstrating substantial equivalence to existing predicate devices (Fraxel® II SR Laser Systems, Lumenis UltraPulse Encore Carbon Dioxide Surgical Laser and Delivery Device Accessories) based on:

Identical or similar indications for use.
Identical key technological characteristics (energy type, operating principle) to at least one of its predicates (K062303).

The statement "The clinical performance data reviewed supported the determination that the Fraxel® SR1500 Laser System and Accessories performs as clinically intended and that no new issues of safety and effectiveness are introduced" indicates that existing clinical data from the predicate devices, or potentially other general clinical understanding of fractional ablative lasers, was sufficient to support the substantial equivalence claim without requiring new, specific performance studies with defined acceptance criteria for this device itself.

Summary

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070284

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT

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

NAME OF DEVICE

Trade Name: Common Name: Regulation Number Product code: Device Panel: Device Classification: Fraxel® SR1500 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) #: K062303

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® SR1500 Laser System consists of a fiber laser, controlled by an embedded processor, to be used in dermatology. The laser system uses scanning and focusing optics

MAY 1 7 2007

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070284

to deliver a controlled pattern of thermal energy to the epidermis and dermis. Device accessories include tip kits and pre-treatment solution.

INDICATION FOR USE STATEMENT

The Fraxel® SR1500 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 for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma:

Skin resurfacing procedures.

SUBSTANTIAL EQUIVALENCE COMPARISON

Indications for Use

Substantial equivalence for the Fraxel® SR1500 Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indication statements. The clinical performance data reviewed supported the determination that the Fraxel® SR1500 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® SR1500 Laser System, such as energy type and operating principle, are identical to the Fraxel® SR1500 Laser System as described in submission K062303.

CONCLUSION

Based on the evaluation described herewithin, the Fraxel® SR1500 Laser System and Accessories is substantially equivalent to the predicate devices currently marketed in accordance with the Federal Food, Drug and Cosmetic Act. Safety and effectiveness were 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 caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAY 1 7 2007

Re: K070284

Trade/Device Name: Fraxel® SR 1500 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: II Product Code: GEX Dated: April 12, 2007 Received: May 4, 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 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 MacFalls

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.

y yours.

Mark N. Mull

M rk 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): ヒロフロスタイ

Fraxel® SR 1500 Laser System and accessories Device Name:___ Indications For Use:

"The Fraxel® SR 1500 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 for treatment of dyschromia and pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis and melasma;

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)

(Division Sign-Off)
Division of General, Restorative, and Neurological Devices	Page 1 of _______
510(k) Number	L070284

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.