The Palomar Lux2940 handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications:

Skin resurfacing .
Treatment of wrinkles .
Epidermal nevi .
Telangiectasia .
Spider veins ●
Actinic chelitis .
Keloids .
Verrucae .
Skin tags .
Anal tags .
Keratoses .
Scar revision (including acne scars) .
Debulking benign tumors .
Debulking cysts .
Superficial skin lesions

Device Description

The Lux2940 handpiece is composed of a system console, cooling system, power supply and handpiece.

AI/ML Overview

The provided 510(k) summary for the Palomar Lux2940 Handpiece indicates that the device's performance was not evaluated through a dedicated study with specific acceptance criteria. Instead, the submission relies on the concept of substantial equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Not applicable	"The specifications and indications for use of the Lux2940 are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information."

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

Not applicable. No dedicated test set was used for performance evaluation as per the provided summary. The device's performance was established by demonstrating substantial equivalence to predicate devices, implying that its performance aligns with those already marketed and deemed safe and effective.

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

Not applicable. No ground truth was established for a test set, as no dedicated performance study was conducted.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication was performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "The specifications and indications for use of the Lux2940 are substantially equivalent to its predicate devices. Thus, [they] do not result in additional safety or effectiveness information." This indicates that a comparative effectiveness study, such as an MRMC study, was not conducted to assess the device's performance or improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

No. The device is a "Handpiece" for an Er: YAG laser system, implying it's a hardware component, not a software algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

Not applicable. No ground truth was established for a direct performance assessment of the Lux2940 Handpiece. Its equivalence was based on technological characteristics and intended use compared to legally marketed predicate devices.

8. Sample Size for the Training Set

Not applicable. The device is a hardware component (laser handpiece), not an AI algorithm that requires a training set.

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

Not applicable. As above, no training set was used.

Summary of Acceptance Criteria and Study Approach:

The regulatory submission for the Palomar Lux2940 Handpiece primarily relies on demonstrating substantial equivalence to already approved predicate devices rather than presenting a performance study with specific acceptance criteria and detailed quantitative results. The core argument is that the Lux2940 Handpiece shares sufficiently similar technological characteristics and intended uses with existing devices (Friendly Light, Contour Profile, Harmony Lovely II, Dermablate) that its safety and effectiveness can be inferred. This approach is common for Class II medical devices seeking 510(k) clearance, where a de novo approval or a Premarket Approval (PMA) requiring extensive clinical trials is not deemed necessary.

Summary

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K063571

510(k) Summary Lux2940 Handpiece

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

1. SUBMITTER'S INFORMATION

NAME:
Palomar Medical Technologies, Inc.

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

9 2007

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

DATE PREPARED: November 28, 2006

2. DEVICE INFORMATION

Palomar Lux2940 Handpiece TRADE/PROPRIETARY NAME:

COMMON/USUAL NAME: Er: YAG laser

CLASSIFICATION NAME:

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

GEX PRODUCT CODE:

PREDICATE DEVICES 3.

Friendly Light (K000023) Innotech USA

Contour Profile (K010285 & K040005) Sciton, Inc.

Harmony Lovely II (K042000) Alma Lasers Inc. (formerly MSq (M2) Ltd.)

Dermablate (K980361) Aesculap-Meditec

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4. INTENDED USE

Intended for coagulation, vaporization, ablation and/or cutting of soft tissue. This includes skin resurfacing, treatment of wrinkles, epidermal nevi, Telangiectasia, spider veins, actinic chelitis, keloids, Verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), debulking benign tumors, debulking cysts and superficial skin lesions

DEVICE DESCRIPTION ട്.

The Lux2940 handpiece is composed of a system console, cooling system, power supply and handpiece.

6. PERFORMANCE DATA

・

The specifications and indications for use of the Lux2940 are substantially equivalent to its predicate devices. Thus, do not result in additional safety or effectiveness information.

7. SUBSTANTIAL EQUIVALENCE

The Lux2940 handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this application demonstrates that the Lux2940 also share the same technological characteristics to its predicates.

2/2

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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 is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, clutching a caduceus in its talons.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

9 2007 FB

Re: K063571 Trade/Device Name: Palomar Lux2940 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: November 27, 2006 Received: November 29, 2006

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 - Ms. Sharon Timberlake, 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 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

For Pablo Perez

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): ___K063571

Device Name: Palomar Lux2940 Handpiece

Indications for Use:

Skin resurfacing .
Treatment of wrinkles .
Epidermal nevi .
Telangiectasia .
Spider veins ●
Actinic chelitis .
Keloids .
Verrucae .
Skin tags .
Anal tags .
Keratoses .
Scar revision (including acne scars) .
Debulking benign tumors .
Debulking cysts .
Superficial skin lesions �

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off)
	Division of General, Restorative, and Neurological Devices

Prescription Use(Per 21 CFR 801.109)	X
	OR
510(k) Number	K063577
	Over-The-Counter Use
	(Optional Format 1-2-96)

PALOMAR MEDICAL TECHNOLOGIES, INC. Lux2940 510(K)

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.