The Palomar Lux1540™ Handpiece is intended for use in: Coagulation of soft tissue; Skin resurfacing procedures; Treatment of melasma and striae; Treatment of acne scars and surgical scars.

Device Description

The Lux1540 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

The provided text is a 510(k) summary for the Palomar Lux1540™ Handpiece, which is a regulatory document submitted to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. This type of document typically focuses on comparing the new device's technical characteristics, intended use, and safety/effectiveness to existing devices, rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics of the device against those criteria.

Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, ground truth methods, and MRMC studies is not present in the provided document.

Here's an breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document instead frames acceptance in terms of "substantial equivalence" to predicate devices. This means the device is considered acceptable if its performance, as demonstrated by technical and safety data, is comparable to devices already cleared by the FDA for the same intended uses.
Reported Device Performance:
- The document states: "The specifications and indications for use of the Lux1540 Handpiece are substantially equivalent to its predicate devices based on the data provided in the 510(k) premarket notification."
- "The Lux1540 Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this 510(k) premarket notification demonstrates that the Lux1540 Handpiece also shares the same technological characteristics, mechanism of action, intended use and physical properties to its predicates."

In summary, the "acceptance criteria" here are met by demonstrating substantial equivalence, meaning the device's performance is deemed acceptable if it performs similarly to established, legally marketed predicate devices for the specified indications.

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

Not explicitly stated in the provided text. 510(k) summaries for laser handpieces often rely on bench testing, electrical safety tests, biocompatibility, and optical performance specifications rather than large-scale clinical test sets with human subjects for performance evaluation in the same way an AI diagnostic device would. If clinical data was used, its details (sample size, provenance) are not included in this summary.

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

Not applicable/Not stated. This document does not describe a study involving human experts establishing ground truth for a test set in the context of an AI-driven diagnostic device. The evaluation is focused on the device's physical and technical characteristics, and its equivalence to predicates.

4. Adjudication Method for the Test Set

Not applicable/Not stated. See point 3.

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

No, an MRMC comparative effectiveness study was not done (or at least, is not mentioned in the provided text). This type of study is specifically relevant for AI-powered diagnostic aids where human interpretation is involved. The Lux1540 Handpiece is a therapeutic laser device, not a diagnostic one.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. The Lux1540 Handpiece is a physical device that requires a human operator for its therapeutic function. It is not an algorithm that performs standalone analysis.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not explicitly described. For a therapeutic laser device seeking 510(k) clearance, "ground truth" often refers to demonstrating that the device meets its technical specifications (e.g., wavelength, power output, spot size, pulse duration) and that these specifications are consistent with effective and safe operation for the stated indications, as supported by scientific literature and predicate device performance. It also relies on a comparative assessment against the known performance and safety profiles of predicate devices.

8. The Sample Size for the Training Set

Not applicable/Not stated. As this is a physical therapeutic device and not an AI algorithm, there is no "training set" in the conventional machine learning sense.

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

Not applicable/Not stated. See point 8.

Summary

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510(k) Summary Lux1540™ Handpiece

Kog 0195

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

SUBMITTER'S INFORMATION 1.

NAME:	Palomar Medical Technologies, Inc.	NOV 20 2009
ADDRESS:	82 Cambridge StreetBurlington, MA 01803Phone: (781) 993-2300Fax: (781) 993-2330
CONTACT:	Sharon Timberlake, MSHS, RAC, CCRADirector of Regulatory Affairs

DATE PREPARED: January 26, 2009

2. DEVICE INFORMATION

TRADE/PROPRIETARY NAME:	Palomar Lux1540™ Fractional Laser Handpiece
COMMON/USUAL NAME:	Lux1540, Lux1540 Handpiece
CLASSIFICATION NAME:	Laser surgical instrument for use in general andplastic surgery and in dermatology(21 CFR § 878.4810)
PRODUCT CODE:	GEX

3. PREDICATE DEVICES

Palomar Medical Technologies, Inc. Lux1540™ Fractional Laser Handpiece K080244

Reliant Technologies, Inc. Fraxel SR1500 Laser System (Fraxel Re:store™) K070284

Cynosure, Inc. Affirm Family Laser with XPL Handpiece K080006

Global USA Distribution, LLC. NannoLight IPL System K082033

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4. INTENDED USE

The Palomar Lux1540 Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures, treatment of melasma and striae, and treatment of acne scars and surgical scars.

DEVICE DESCRIPTION న్.

The Lux1540 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.

PERFORMANCE DATA 6.

The specifications and indications for use of the Lux1540 Handpiece are substantially equivalent to its predicate devices based on the data provided in the 510(k) premarket notification.

7. SUBSTANTIAL EQUIVALENCE

The Lux1540 Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this 510(k) premarket notification demonstrates that the Lux1540 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 and Human Services. The logo features a stylized eagle or bird-like symbol 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 bird symbol.

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

Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake Director of Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803

NOV 2 0 2009

Re: K090195

Trade/Device Name: PalomarLux 1540™ Handpiece

Regulation Number: 21 CFR 878.4810

Regulation Name: Laser surgical instrument for use in genera and plastic surgery and in dermatology

Regulatory Class: II Product Code: GEX Dated: June 23, 2009 Received: June 24, 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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. Sharon Timberlake

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 vours.

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Mark N. Melkerson 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

510(k) Number (if known):	K090195
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Device Name: PalomarLux1540™ Handpiece

Indications for Use:

The Palomar Lux1540™ Handpiece is intended for use in:

Coagulation of soft tissue; Skin resurfacing procedures; Treatment of melasma and striae; Treatment of acne scars and surgical scars.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 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)

Nilser Aal for mxm
(Division Sign-off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090195

Page 1 of 1

CONFIDENTIAL

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.