The Erbium Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.

Device Description

The Erbium Fractional Handpiece attaches to the StarLux Pulsed Light and Laser Systems. The complete system consists of a cart, system console, chiller, a footswitch, and a handpiece.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the Erbium Fractional Handpiece:

Acceptance Criteria and Device Performance Study for K083900 - Erbium Fractional Handpiece

Based on the provided 510(k) summary, the device's acceptance criteria and performance are established through a claim of substantial equivalence to predicate devices, rather than a new clinical study with specific acceptance criteria metrics.

The document explicitly states:
"The specifications and indications for use of the Erbium Fractional are substantially equivalent to its predicate devices based on the data provided in premarket notification. Thus, it does not result in additional safety or effectiveness information."

And:
"The Erbium Fractional Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this premarket notification demonstrates that the Erbium Fractional Handpiece also shares the same technological characteristics, mechanism of action, intended use and physical properties to its predicates."

This means that no new, independent study was conducted to demonstrate the device's performance against specific, pre-defined acceptance criteria. Instead, the FDA cleared the device based on its similarity to previously approved devices. Therefore, the following information is largely not applicable or not explicitly detailed in the provided document, as a traditional performance study was not conducted for this specific 510(k) filing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Applicable - Performance established through substantial equivalence to predicate devices.	The device shares the same technological characteristics, mechanism of action, intended use, and physical properties as its predicate devices: - Palomar Erbium Fractional Handpiece (K071768) - Palomar Erbium Handpiece (K071152, K063571) - Palomar Lux1540 Fractional Handpiece (K080244) - Reliant Technologies, Inc. Fraxel III SR Laser System (Fraxel Re:Pair™) (K080915)

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

Sample Size for Test Set: Not applicable. No new test set data was reported for this 510(k) submission. Performance was established via substantial equivalence.
Data Provenance: Not applicable. The submission relies on data previously reviewed and accepted for the predicate devices.

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

Number of Experts: Not applicable. No new test set requiring expert ground truth establishment was conducted.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No new test set was evaluated.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done for this submission. The device's clearance is based on substantial equivalence.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable. This device is not an AI-assisted diagnostic tool; it is a laser handpiece for dermatological procedures.

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

Standalone Performance: Not applicable. This device is a medical instrument (laser handpiece), not a software algorithm or AI.

7. The Type of Ground Truth Used

Type of Ground Truth: Not applicable for this specific 510(k) submission, as performance was demonstrated through substantial equivalence. The predicate devices would have relied on appropriate clinical data (e.g., expert clinical assessment, histopathology) to establish their safety and effectiveness.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a laser handpiece, not an algorithm that requires a training set.

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

How Ground Truth for Training Set Was Established: Not applicable. This device is a laser handpiece, not an algorithm that requires a training set.

Summary of K083900's Clearance Basis:

The Erbium Fractional Handpiece (K083900) received 510(k) clearance by demonstrating substantial equivalence to existing predicate devices. This means the manufacturer successfully argued that their new device shares fundamental technological characteristics, intended use, mechanism of action, and physical properties with devices already on the market that have been deemed safe and effective. Therefore, no new clinical performance studies, test sets, or training sets were required for this specific submission to prove safety and effectiveness beyond what was already established for the predicates.

Summary

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K083960

FEB 2-7 2009

510(k) Summary Erbium Fractional Handpiece

This 510(k) summary is being submitted in accordance with 21 CFR 807.92

1. SUBMITTER'S INFORMATION

Palomar Medical Technologies, Inc. NAME:

82 Cambridge Street ADDRESS: Burlington, MA 01803 Phone: (781) 993-2300 Fax: (781) 993-2330

Sharon Timberlake, MSHS, RAC, CCRA CONTACT: Director of Regulatory Affairs

DATE PREPARED: February 5, 2009

2. DEVICE INFORMATION

Erbium Fractional Handpiece TRADE/PROPRIETARY NAME:

Dermatological Erbium Laser Common/Usual Name:

Laser surgical instrument for use in general and CLASSIFICATION NAME: plastic surgery and in dermatology (21 CFR § 878.4810)

GEX Product Code:

PREDICATE DEVICES 3.

Palomar Medical Technologies, Inc. Palomar Erbium Fractional Handpiece K071768

Palomar Medical Technologies, Inc. Palomar Erbium Handpiece K071152, K063571

Palomar Medical Technologies, Inc. Lux1540 Fractional Handpiece K080244

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083900

Reliant Technologies. Inc. Fraxel III SR Laser System (Fraxel Re:Pair™) K080915

INTENDED USE 4.

న్. DEVICE DESCRIPTION

The Erbium Fractional Handpiece attaches to the StarLux Pulsed Light and Laser The complete system consists of a cart, system console, chiller, a Systems. footswitch, and a handpiece.

PERFORMANCE DATA 6.

The specifications and indications for use of the Erbium Fractional are substantially equivalent to its predicate devices based on the data provided in Thus, it does not result in additional safety or premarket notification. effectiveness information.

SUBSTANTIAL EQUIVALENCE 7.

The Erbium Fractional Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this premarket notification demonstrates that the Erbium Fractional Handpiece also shares the same technological characteristics, mechanism of action, intended use and physical properties to its predicates.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

ood and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Palomar Medical Technologies, Inc. % Sharon Timberlake, MSHS, RAC, CCRA 82 Cambridge Street Burlington, Massachusetts

FEB 2 7 2009

Re: K083900

Trade/Device Name: Erbium Fractional Handpiece 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: December 24, 2008 Received: December 29, 2009

Dear Ms. Timberlake:

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 - Sharon Timberlake, MSHS, RAC, CCRA

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,

Mark. N. Mulheran

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): _KO8 3 900

Device Name: Erbium Fractional Handpiece

Indications for Use:

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)

Milne Bylin for mxm

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

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510(k) Number K083900

PALOMAR MEDICAL TECHNOLOGIES, INC. TRADITIONAL 510(K): ERBIUM FRACTIONAL HANDPIECE

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.