1550 nm: The Fraxel re:store 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It is also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.

1927 nm: The Fraxel re:store 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and the treatment of actinic keratosis.

Device Description

The Fraxel re:store® Dual Laser System consists of a 1550 nm laser source and a 1927 nm laser source with fiber delivery and control by an embedded processor for use in dermatological procedures. 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

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes a 510(k) submission for the Fraxel re:store® Dual Laser System. For a 510(k) submission, the primary acceptance criterion is substantial equivalence to a previously legally marketed predicate device. This means the new device must be as safe and effective as the predicate device.

The study presented focuses on demonstrating the safety and efficacy of the 1927 nm wavelength for the treatment of actinic keratosis, which is an added indication compared to the predicate device.

Given this, the acceptance criteria and reported device performance can be summarized as follows:

Acceptance Criterion (for 1927 nm wavelength for Actinic Keratosis)	Reported Device Performance
Safety: Device operation does not introduce new safety concerns.	Histological analysis demonstrated the safety. Side effects were minimal and well tolerated in clinical studies.
Efficacy: Device effectively treats actinic keratosis.	Clinical studies demonstrated efficacy in the treatment of actinic keratosis.
Substantial Equivalence: Device is as safe and effective as the predicate device for its stated indications, and for the new indication, demonstrates comparable safety and efficacy.	Demonstrated that the Fraxel re:store Dual® Laser System performs as intended and that no new issues of safety and effectiveness are introduced. Concluded to be substantially equivalent to predicate devices.

Study Details:

The provided text describes both pre-clinical and clinical studies.

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

Pre-clinical Study:
- Sample Size: Not explicitly stated as a number, but involved "pig skin and excised human abdominal tissue."
- Data Provenance: Not specified (e.g., country of origin). The phrase "excised human abdominal tissue" suggests human tissue samples, likely from a tissue bank or surgical waste.
Clinical Study:
- Sample Size: Not explicitly stated.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). Given it's a clinical study for product clearance, it's highly likely to be a prospective study.

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 text. The histological analysis would have been performed by pathologists/histologists, and the clinical efficacy and safety would have been assessed by dermatologists or other qualified medical professionals, but their number and specific qualifications are not detailed.

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

This information is not provided in the text.

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 device is a laser system for dermatological procedures, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

Again, this device is a laser system, not an algorithm or AI. Standalone algorithmic performance is not applicable here. The device's performance is intrinsically linked to its direct physical interaction with tissue, potentially guided by human operators.

7. The type of ground truth used:

Pre-clinical Study:
- Histological analysis: The ground truth for lesion characteristics (depth and width) was established directly through microscopic examination of tissue.
Clinical Study:
- Clinical assessment: The ground truth for safety and efficacy in treating actinic keratosis was based on clinical observations and assessments by medical professionals, likely involving visual inspection, possibly biopsies, and patient reported outcomes.

8. The sample size for the training set:

This information is not applicable as the document describes a medical device (laser system) and its performance studies, not a machine learning or AI algorithm that requires a "training set."

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

This information is not applicable as described in point 8.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

DATE OF SUBMISSION

September 7, 2010

REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

COMPANY NAME/CONTACT

Kristine Foss Solta Medical, Inc. 25881 Industrial Blvd Hayward, CA 94545 510-780-4657 phone 510-780-4857 fax kfoss@solta.com

NAME OF DEVICE

Trade Name:

Common Name:
Regulation Number
Product code:
Device Panel:
Device Classification:

Fraxel re:store® Dual Laser System and Accessories Laser Surgical Instrument 878.4810 GEX General Surgery/Restorative Devices Class II

LEGALLY MARKETED PREDICATE DEVICES

Name: Fraxel re:store Laser System and Accessories 510(k) #: K060310

Name: Fraxel re:store® Dual Laser System and Accessories 510(k) #: K091420

1101490 SEP 0 8 2010

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DEVICE DESCRIPTION

INDICATION FOR USE STATEMENT

Indications for use:

1550 nm: The Fraxel re:store® Dual 1550 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures. It also indicated for treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars.

1927 nm: The Fraxel re:store 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and the treatment of actinic keratosis.

SUBSTANTIAL EQUIVALENCE COMPARISON

Indications for Use

Substantial equivalence for the Fraxel re:store® Dual Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indication statements. Histological and clinical performance data confirmed that the Fraxel re:store Dual® Laser System performs as intended and that no new issues of safety and effectiveness are introduced.

Technological Characteristics

Key technological characteristics of the Fraxel re:store® Dual Laser System, such as energy type and operating principle, are identical to the Fraxel re:store® Dual Laser System described in submission K091420. In particular, the 1550 nm and 1927 nm laser sources and delivery systems are identical. Energy is delivered through the same handpiece for both systems. There are no changes in system software or user interface for the Fraxel re:store® Dual Laser System, which is the subject of this submission, and the device of the predicate submission K091420.

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Pre-clinical and Clinical Studies

Pre-clinical Studies

Histological analysis of lesion characteristics (depth and width) created by the 1927 nm wavelength laser in pig skin and excised human abdominal tissue (included in the original Fraxel re:store Dual submission K091420) demonstrated the safety of this wavelength in treating the added indication of actinic keratosis.

Clinical Studies

In clinical studies, safety and efficacy of the 1927 nm wavelength in the treatment of actinic keratosis was demonstrated, and side effects were minimal and well tolerated.

CONCLUSION

Based on the evaluation described within, the Fraxel re:store® Dual Laser System 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/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol, with three lines forming a shape resembling a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Solta Medical, Inc. % Ms. Kristine Foss Vice President, Regulatory, Clinical and Quality 25881 Industrial Boulevard Hayward, California 94545

SEP 0 8 2010

Re: K101490

Trade/Device Name: Fraxel re:store® Dual 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: ONG Dated: August 19, 2010 Received: August 23, 2010

Dear Ms. Foss:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Kristine Foss

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mark N. Melkersor Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

SEP 0 8 2010

510(k) Number K101490:

Device Name: Fraxel re:store® Dual Laser System and Accessories

Indications for use:

1927 nm: The Fraxel re:store 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue and the treatment of actinic keratosis.

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/onDevice Evaluation (ODE)

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

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.