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.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving the device meets particular criteria in terms of numerical performance metrics. Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices.

However, based on the Clinical Performance Data section, we can infer the overarching acceptance criteria and the nature of the study:

Inferred Acceptance Criteria:

The primary acceptance criteria were that the Fraxel SR Laser System:

Functioned as clinically intended.
Performed as clinically intended.
Introduced no new issues of safety and effectiveness compared to predicate devices.

Study that Proves the Device Meets Acceptance Criteria:

A "clinical investigation" was conducted.

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Device functions as clinically intended	"The Fraxel SR Laser System functioned as clinically intended."
Device performs as clinically intended	"The Fraxel SR Laser System performs as clinically intended"
No new safety/effectiveness issues	"no new issues of safety and effectiveness are introduced."
Substantially equivalent to predicates	"The Fraxel SR Laser System is substantially equivalent to the devices currently marketed..."

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The text only mentions "Clinical performance data was used" and "The results from clinical investigation."
Data Provenance: Not explicitly stated. It is a "clinical investigation," which typically implies prospective data from human subjects. However, the country of origin is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The type of "clinical investigation" and how effectiveness was judged (e.g., by experts) is not detailed.

4. Adjudication method for the test set:

This information is not provided in the document.

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:

This is not applicable. The device is a "Dermatology Laser" system, not an AI software intended for interpretation by human readers. Therefore, an MRMC study and effect size for human reader improvement with AI assistance are not relevant to this device's evaluation.

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

This is not applicable. The Fraxel SR Laser System is a physical laser device used by a clinician, not a standalone algorithm.

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

The document mentions "clinical investigation" and demonstrating that the system "functioned as clinically intended" and "performs as clinically intended." This strongly suggests that clinical outcomes data (e.g., observed changes in skin, reduction in wrinkles/scars, efficacy in pigmented lesion treatment) were used. Pathology might be relevant for some indications but is not explicitly stated as the ground truth method.

8. The sample size for the training set:

The document describes a "clinical investigation" for performance data. It does not mention a "training set" in the context of machine learning, as this is a physical device, not an AI algorithm. Therefore, "training set" information is not applicable.

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

As explained in point 8, a "training set" in the machine learning sense is not applicable to this device description.

Summary

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Kos 3047

APPENDIX A 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

A - l

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<05 7047

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. Is provincing a as well as the substantial equivalence decision making process.

Submitter:	Reliant Technologies, Inc.
Address:	464 Ellis St.Mountain View, CA 94043
Contact Person:	Heather TannerClinical and Regulatory Affairs
Telephone:	(650) 641-5861
Facsimile:	(650) 641-3641
Date prepared:	October 27, 2005
Device Trade Name:	Fraxel SR Laser System
Common Name:	Dermatology Laser
Classification Name:	Laser Surgical Instrument21 C.F.R § 878.4810

Legally Marketed Predicate Devices:

Fraxel SR Laser System K050841 Candela VBeam K033461 Candela CBcam K033331 Candela Smoothbeam K041242 CoolTouch CT3 K043046 Lumenis Ultrapulse Encore K022060

Description of the 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;

Treatment of surgical scars and acne scars;

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

Skin resurfacing procedures.

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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.

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

Clinical performance data was used to demonstrate that the Fraxel SR Laser System functioned as clinically intended. The results from clinical investigation allowed for the determination that the Fraxel SR Laser System performs as clinically intended and that no new issues of safety and effectiveness are introduced.

Conclusion

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

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract image of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle image. The seal is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2006

Reliant Technologies, Inc. c/o Ms. Heather Tanner Clinical Research/Regulatory Affairs Manager 464 Ellis Street Mountain View, California 94043

Re: K053047

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: February 16, 2006 Received: February 17, 2006

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

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Page 2 - Ms. Heather Tanner

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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

emde

Mark N. Melkerson 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 (if known): K053047

Device Name:

Indications For Use:

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

Dermatological procedures requiring the coagulation of soft tissue;

Treatment of periorbital wrinkles;

Treatment of surgical scars and acne 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)

.gride

Division of General. Restorative. and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.