The Palomar Erbium 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 Palomar Erbium Handpiece attaches to the StarLux Pulsed Light and Laser System. 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 Erbium Handpiece. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance data in the format requested.

Therefore, many of the requested details cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be answered based solely on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be fully provided. The document states: "The review of the technical characteristics, indications for use, mechanism of action, and verification and validation information provided demonstrate that the modified Palomar Erbium Handpiece is substantially equivalent to its predicate device." This is a general statement about equivalence and does not provide specific performance metrics or acceptance criteria for the new device. It implies that the new device performs similarly to the predicate, but the exact performance data and acceptance thresholds are not disclosed in this summary.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

*   **Note:** The core of a 510(k) submission for substantial equivalence often involves demonstrating that the new device meets the same performance specifications as the predicate or that any differences do not raise new questions of safety and effectiveness. These specific performance metrics are typically included in the full submission but not in the public summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be determined. The summary does not mention any clinical study involving a "test set" with a specific sample size, data provenance, or study design (retrospective/prospective). The assessment appears to be based on technical characteristics and verification/validation, likely non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be determined. The summary does not describe a process for establishing ground truth using experts, as no clinical study or test set requiring such a process is mentioned.

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

Cannot be determined. No adjudication method is mentioned because no clinical study is described.

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. This device is a laser handpiece for surgical applications, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is not applicable and was not performed.

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

Not applicable. This device is a physical medical instrument (laser handpiece), not an algorithm or software. It requires a human operator (surgeon/dermatologist) for its intended use. Performance is inherently "human-in-the-loop," as the device is a tool operated by a medical professional.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be determined (and likely not applicable in the way implied). For a medical device like a laser handpiece, "ground truth" related to its function would typically be based on engineering specifications, safety testing (e.g., power output, beam quality, tissue interaction in in-vitro or ex-vivo models), and potentially limited clinical observations for safety and efficacy endpoints (like wound healing, scar reduction, etc. as observed by clinicians). The summary does not detail these, instead relying on equivalence to a predicate.

8. The sample size for the training set

Not applicable. This device is a physical instrument, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set for a machine learning model, this question is not relevant to the device described.

In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence to a previously cleared device. It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment methods that would be characteristic of a clinical validation study for a diagnostic device or an AI/ML product. The "Performance Data" section explicitly states that the determination is based on a "review of the technical characteristics, indications for use, mechanism of action, and verification and validation information," indicating a non-clinical evaluation for equivalence.

Summary

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510(k) Summary Palomar Erbium Handpiece

K071152

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 Phone: (781) 993-2300 Fax: (781) 993-2330

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

DATE PREPARED: April 24, 2007

2. DEVICE INFORMATION

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

3. PREDICATE DEVICE

Lux2940 Handpiece K063571 Palomar Medical Technologies, Inc.

4. INTENDED USE

Intended for coagulation, vaporization, ablation and/or cutting of soft tissue. This includes skin resurfacing, treatment of wrinkles, epidermal nevi, telangicctasia, 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.

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DEVICE DESCRIPTION 5.

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

PERFORMANCE DATA 6.

The review of the technical characteristics, indications for use, mechanism of action, and verification and validation information provided demonstrate that the modified Palomar Erbium Handpiece is substantially equivalent to its predicate device.

7. SUBSTANTIAL EQUIVALENCE

The Palomar Erbium Handpiece was found to be substantially equivalent to its predicate device when used according to its intended use. The information that is provided in this application demonstrates that the Palomar Erbium Handpiece also shares the same technological characteristics as its predicate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food 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

Re: K071152

Trade/Device Name: Palomar Erbium 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: April 24, 2007 Received: April 26, 2007

MAY 2 5 2007

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, "Mishranding 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,
Mark McMahon

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): ____________________________________________________________________________________________________________________________________________________

Device Name: Palomar Erbium 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 .

Mark A. Miller

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

510(k) Number K071152

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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.