The Alma Lasers Family of Thermo-XEL Handpieces is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue for compatible CO2 and 2940 nm Er:YAG laser systems cleared for use in the medical specialty of Dermatology and Plastic Surgery to which they are attached.

The Alma Lasers Family of Thermo-XEL Handpieces is indicated for use in soft tissue for: DERMATOLOGY AND PLASTIC SURGERY: Skin resurfacing

Device Description

The Alma Lasers Family of Thermo-XEL Handpieces is comprised of the following main components: Thermo-XEL Handpiece body. Adapter attachments: CO2 laser adapter attachment, as required, to attach the handpiece body to the qualified CO2 or Er: Y AG laser system Er:YAG laser adapter attachment, as required, to attach the handpiece body to the qualified Er: Y AG laser system

The Alma Lasers Family of Thermo-XEL Handpieces are provided as a non-sterile, cleanable, multiple use laser energy delivery device (accessory). The proximal end of the handpiece is designed to be attached, using the laser adapter, to the distal end of the articulated arm of compatible CO2 (10.6 um) or Er.YAG (2940 nm) laser systems as qualified by Alma Lasers for use with the Thermo-XEL Handpiece.

AI/ML Overview

This document is a 510(k) premarket notification for the Alma Lasers Family of Thermo-XEL Handpieces, submitted to the FDA in 2008. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that defines and met specific acceptance criteria for a new, novel device performance claim. Therefore, much of the requested information regarding acceptance criteria and performance studies is not present in this type of submission.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable for this 510(k) submission.

This document is a "substantial equivalence" claim. For devices pursuing substantial equivalence, the primary "acceptance criterion" is that the device is as safe and effective as a legally marketed predicate device. This is typically demonstrated through comparing indications for use, operating principles, technological characteristics, and performance data if relevant to the comparison, rather than establishing and meeting novel performance metrics.

The document states: "The Alma Lasers Family of Thermo-XEL Handpieces shares the same or similar indications for use, operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices." It also explicitly mentions: "The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers Family of Thermo-XEL Handpieces is substantially equivalent to the predicate devices."

Therefore, the "reported device performance" is implicitly that it performs equivalently to the listed predicate devices in terms of its intended use (ablation, vaporization, and coagulation of soft tissue for skin resurfacing) when attached to compatible CO2 and Er:YAG laser systems. No specific quantitative performance metrics or acceptance criteria are defined or reported.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided in this 510(k) submission.

This submission does not detail specific "test sets" or clinical studies with human subjects, as it relies on substantial equivalence to predicate devices. The "data provenance" mentioned would refer to the characteristics and performance of the predicate devices already on the market.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided in this 510(k) submission.

There is no mention of a test set requiring ground truth established by experts.

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

Not applicable/Not provided in this 510(k) submission.

There is no mention of a test set requiring adjudication.

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

Not applicable.

This device is a laser handpiece, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

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 a software algorithm.

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

Not applicable/Not provided in this 510(k) submission.

As no specific study with a test set requiring ground truth is described, this information is not present. The "ground truth" for a substantial equivalence determination largely rests on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable/Not provided in this 510(k) submission.

There is no mention of a "training set" as this is not an AI/machine learning device. The design and validation of this device would rely on engineering principles, materials testing, and performance testing against established safety standards rather than a data-driven training set.

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

Not applicable/Not provided in this 510(k) submission.

As there is no training set, this information is not available.

Summary of this 510(k) context:

This 510(k) submission (K072182) for the Alma Lasers Family of Thermo-XEL Handpieces is a regulatory filing that seeks to demonstrate "substantial equivalence" to pre-existing, legally marketed predicate devices. This pathway does not typically require the detailed clinical studies, acceptance criteria, and performance metrics that would be associated with a novel device or an AI/software device. Instead, the manufacturer compares the new device's indications for use, design, and technological characteristics to those of predicate devices to establish that it is "as safe and effective" as those already on the market. Therefore, the specific types of performance data, test sets, and ground truth methodologies you've requested are generally not found in this type of submission.

Summary

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K672182

JUN 2 7 2008

Section 5 - 510(k) Summary or 510(k) Statement

I. General Information

Submitter:	Alma Lasers, Ltd.14 Halamish Street (PO Box 3021), Industrial Park,Caesarea, 38900ISRAEL
Contact Person:	Tatiana EpsteinRegulatory Affairs Manager
Summary Preparation Date:	June 12, 2008

II. Names

Device Names:	Alma Lasers Family of Thermo-XEL Handpieces
---------------	---------------------------------------------

Primary Classification Names: Accessory for, Laser Powered Surgical Instruments

III. Predicate Devices

Lasering SLIM Evolution Family of CO2 Lasers and Accessories (K063001) .
. Lumenis ActiveFx with UltraPulse Encore (K022060)
. Lumenis UltraPulse with Scanner (K963339 and K951812)
Reliant Technologies Fraxel SR1500 Laser Systems and Accessories (K070284) .
. MSq Family of Lovely Light/Laser Systems (K042000)
. Alma Lasers Harmony XL Multi-Application Platform and Thermoelectric Cooler (K072564)

IV. Product Description

The Alma Lasers Family of Thermo-XEL Handpieces is comprised of the following main components:

Thermo-XEL Handpiece body .
. Adapter attachments:
- CO2 laser adapter attachment, as required, to attach the handpiece body to the qualified CO2 or Er: Y AG laser system
- ১ Er:YAG laser adapter attachment, as required, to attach the handpiece body to the qualified Er: Y AG laser system

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V. Indications for Use

The Alma Lasers Family of Thermo-XEL Handpieces is indicated for use in soft tissue for:

DERMATOLOGY AND PLASTIC SURGERY:

� Skin resurfacing

VI. Rationale for Substantial Equivalence

The Alma Lasers Family of Thermo-XEL Handpieces shares the same or similar indications for use, operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.

VII. Safety and Effectiveness Information

The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers Family of Thermo-XEL Handpieces is substantially equivalent to the predicate devices.

VIII. Conclusion

The Alma Lasers Family of Thermo-XEL Handpieces was found to be substantially equivalent to the predicate devices.

The Alma Lasers Family of Thermo-XEL Handpieces shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices.

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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 its wings spread, facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 7 2008

Alma Lasers Ltd. % A. Worden Consulting Ms. Anne Worden Regulatory Consultant 3637 Bernal Avenue Pleasanton, CA 94566

Re: K072182

Trade/Device Name: Alma Lasers Family of Thermo-XEL Handpieces 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: June 12, 2008 Received: June 13, 2008

Dear Ms. Worden:

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

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Page 2 - Ms. Anne Worden

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.

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 M. Milliman

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 Statement

510(k) Number (if known): K072182

Device Name: Alma Lasers Family of Thermo-XEL Handpieces

Indications for Use:

The Alma Lasers Family of Thermo-XEL Handpieces is indicated for use in soft tissue for: DERMATOLOGY AND PLASTIC SURGERY:

· Skin resurfacing

V Prescription Use (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)

FOR M. MATELKERSON

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

510(k) Number K072182

Page 1 of 1

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.