1550 nm: The Fraxel 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 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).

Device Description

The Fraxel DUAL 1550/1927 nm 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

The provided text is a 510(k) summary for the Fraxel DUAL 1550/1927 nm Laser System. It focuses on demonstrating substantial equivalence to predicate devices for expanded indications of the 1927 nm laser.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of specific metrics (e.g., success rates, percentage improvement). Instead, the acceptance criterion for regulatory clearance is based on demonstrating substantial equivalence to existing legally marketed predicate devices and that expanded indications do not raise new issues of safety and effectiveness.

Acceptance Criterion (Implicit)	Reported Device Performance (from "Performance Data" section)
Substantial Equivalence	"A clinical study was conducted to support a determination of substantial equivalence to the predicate device, the Fraxel DUAL 1550/1927 Laser System (K101490)."
Safety and Effectiveness for New Indications	"The clinical performance data confirmed that the Fraxel DUAL 1550/1927 Laser System performs as intended and that the expansion of the new 1927 nm indications do not raise new issues of safety and effectiveness."

Study Description:

A "clinical study" was conducted. The primary goal of this study was to:

Confirm that the Fraxel DUAL 1550/1927 nm Laser System performs as intended.
Demonstrate that the expanded indications for the 1927 nm laser do not introduce new safety and effectiveness concerns compared to the predicate device.

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

Sample Size: The document states that "A clinical study was conducted" but does not specify the sample size for this study.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide information regarding:

The number of experts used to establish ground truth.
The qualifications of those experts.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on the device's performance against a predicate, not how human readers' performance improves with or without the device.

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

This device is a physical laser system for dermatological procedures, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance)" study does not apply to this device.

7. The Type of Ground Truth Used

The document implies that "clinical performance data" was collected to confirm the device performs as intended and to assess safety and effectiveness for the expanded indications. However, it does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). In the context of a laser treatment for skin conditions, this would likely involve clinical assessments by dermatologists, possibly photographic documentation, and patient-reported outcomes, but the document does not elaborate.

8. The Sample Size for the Training Set

This device is a physical laser system, not an AI or machine learning algorithm that requires a "training set." Therefore, the concept of a training set does not apply.

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

As stated above, the concept of a training set does not apply to this device.

Summary

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SECTION 5: 510(k) SUMMARY STATEMENT

This 510(k) summary is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990, 21 CFR 807.92

1. General Information

Date of Submission: January 25, 2013

Submitted By:

Solta Medical, Inc. 25881 Industrial Blvd. Hayward, CA 94545

Contact Person:

Raymond Lee Sr. Director, Regulatory Affairs 510-259-7159 (Direct Phone) 510-780-4931 Fax rflee@solta.com

2. Trade/Proprietary Name of Device:

Trade Name:	Fraxel® DUAL 1550/1927 Laser System
Common Name:	Laser Surgical Instrument
Regulation Number	878.4810
Product Code:	GEX
Device Panel:	General Surgery/Restorative Devices
Device Classification:	Class II

3. Legally Marketed Predicate Devices for Claimed Equivalence:

Fraxel® DUAL 1550/1927 Laser System Name: 510(k) #: K101490

Fraxel® Re:fine Laser System Name: 510(k) #: K063808

4. Device Description

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5. Indications for Use Statement

6. Substantial Equivalence Comparison

Indications for Use

Substantial equivalence for the Fraxel DUAL 1550/1927 nm Laser System and Accessories is supported by the predicate devices listed in this submission, which have identical or similar indications statements. Clinical performance data confirmed that the Fraxel DUAL 1550/1927 nm Laser System performs as intended and that no new issues of safety and effectiveness are introduced.

Technological Characteristics

Key technological characteristics of the Fraxel DUAL 1550/1927 nm Laser System, such as energy type and operating principle, are identical to the Fraxel DUAL 1550/1927 nm Laser System described in submission K101490. No changes were made to the mode of operation and fractional delivery of the 1550 and 1927 nm laser sources.

Performance Data

A clinical study was conducted to support a determination of substantial equivalence to the predicate device, the Fraxel DUAL 1550/1927 Laser System (K101490). The clinical performance data confirmed that the Fraxel DUAL 1550/1927 Laser System performs as intended and that the expansion of the new 1927 nm indications do not raise new issues of safety and effectiveness.

Substantial Equivalence Statement

When compared to the predicate devices, the additional indications for use of the Fraxel Dual 1550/1927 Laser System do not raise new issues of safety and effectiveness.

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K130193

Therefore, based on the similarities in technological features, mode of operation, laser-tissue interaction, clinical performance, and intended use, the modified Fraxel DUAL 1550/1927 Laser System is substantially equivalent to the predicate devices marketed under the Federal Food, Drug and Cosmetic Act.

7. Conclusion

The Fraxel DUAL 1550/1927 nm Laser System is substantially equivalent to the predicate devices currently marketed in accordance with the Federal Food, Drug and Cosmetic Act. Based on clinical performance data, the addition to the indications for use raises no new safety and effectiveness questions.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 14, 2013

Solta Medical, Inc. % Mr. Raymond Lee Senior Director, Regulatory Affairs 25881 Industrial Boulevard Hayward, California 94545

Re: K130193

Trade/Device Name: Fraxel Dual 1550/1927 nm 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: Class II Product Code: GEX Dated: April 17, 2013 Received: April 18, 2013

Dear Mr. Lee:

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.

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 - Mr. Raymond Lee

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

FOR

Peter D. Rumm-S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K130193 510(k) Number (if known):

Device Name: Fraxel DUAL 1550/1927 nm Laser System and Accessories

Indications For Use:

1550 nm: The Fraxel 1550 mm 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 1927 nm laser is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actimic keratosis, and treatment of pigmented lessons such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogdent 2013.06.13 115:57:49 -04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

K130193 510(k) Number_

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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.