LightSheer® Pulsed Diode Array Laser Systems are indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer® Pulsed Diode Array Laser Systems are intended for use on all skin types (Fitzpatrick skin types I – VI), including tanned skin.

LightSheer® Duet™ Laser Systems with LightSheer® ET™ Laser Handpiece is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The LightSheer® Duet™ Laser System with LightSheer® ET™ Laser Handpiece is also intended for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins.

LightSheer® Duet™ Laser Systems with LightSheer® HS™ Laser Handpiece is intended for the treatment of benign vascular and pigmented lesions, hair removal, and permanent hair reduction.

Device Description

The LightSheer Duet Laser System is a non-invasive aesthetic laser. The system delivers pulsed infrared laser light with a wavelength ranging from 790 - 950 nm (800 nm nominal) and has two unique treatment handpieces. One handpiece is the LightSheer® ET™ handpiece, which delivers laser energy through a 9 x 9 mm tip up to 90 J maximum. The settings for this handpiece are selectable pulse duration from 5 – 400 ms, selectable fluence from 10 - 100 J/cm2 and a pulse repetition rate up to 3 Hz maximum. The second handpiece is the LightSheer® HS™ handpiece, which delivers laser energy from a 22 x 35 mm diode array up to 45 J maximum. The settings for this handpiece are pulse duration from 10 - 30 ms, selectable fluence from 3 - 5.2 J/cm2 and multiple pulsing up to 3 pulses.

The complete system consists of a console and two handpieces connected to the system by umbilical cables. In standard use, the handpiece is pressed against the patient's skin and a pulse of light is delivered. To initiate energy output, the system requires redundant activation of the handpiece enable button and the handpiece trigger button while the system is in the Ready mode. The LightSheer ET handpiece tip is watercooled to provide active skin cooling. The LightSheer HS handpiece tip uses vacuum and lower laser energy densities which reduces skin heating. The physician is able to control the settings of laser energy from the LCD display on the main console.

AI/ML Overview

This section of the 510(k) submission for the Lumenis LightSheer® Duet™ Laser System is focused on establishing substantial equivalence to predicate devices, rather than presenting a study demonstrating new acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, device performance tables, sample sizes, expert involvement, and ground truth establishment is not present in the provided text.

Here's an analysis of the information that is available, and an indication of what is missing based on your request:

1. Table of acceptance criteria and the reported device performance:

Not provided. This document does not detail specific performance acceptance criteria for the LightSheer Duet Laser System nor does it provide a table of reported device performance against such criteria. The submission aims to demonstrate "substantial equivalence" to predicate devices, implying that if the new device is sufficiently similar to an already cleared device, it doesn't need to meet new, separate performance criteria in the same way a novel device might.

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

Not applicable/Not provided. No specific test set or clinical study data is presented in this document to support new performance claims. The submission relies on demonstrating equivalence rather than new clinical proof.

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):

Not applicable/Not provided. As no new clinical study data with ground truth establishment is presented, this information is not available.

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

Not applicable/Not provided. See above.

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/Not provided. This device is a laser system, not an AI-powered diagnostic tool requiring human reader studies or AI assistance.

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

Not applicable/Not provided. This device is a treatment system, not a standalone diagnostic algorithm.

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

Not applicable/Not provided. See above.

8. The sample size for the training set:

Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable/Not provided. See above.

Summary of what is provided in the text:

The provided text from the 510(k) submission for the Lumenis LightSheer® Duet™ Laser System focuses on describing the device and establishing its substantial equivalence to predicate devices already cleared by the FDA.

Device Description: The document details the LightSheer Duet Laser System as a non-invasive aesthetic laser with two handpieces (LightSheer® ET™ and LightSheer® HS™) delivering pulsed infrared laser light. It describes their specifications (wavelength, fluence, pulse duration, spot size) and skin cooling mechanisms.
Intended Use: The device is indicated for surgical, aesthetic, and cosmetic applications in general and plastic surgery, and dermatology, for all Fitzpatrick skin types (I-VI), including tanned skin. Specific indications for each handpiece include:
- LightSheer® ET™: Treatment of vascular lesions (angiomas, hemangiomas, telangiectasia, other benign vascular lesions), pseudofolliculitis barbae, hair removal, permanent hair reduction, benign pigmented lesions, and leg veins.
- LightSheer® HS™: Treatment of benign vascular and pigmented lesions, hair removal, and permanent hair reduction.
Substantial Equivalence Claim: The core of this submission, as indicated by the "Substantial Equivalence" section, is that the specifications and indications for use of the LightSheer Duet Laser System are "the same or very similar" to those of its claimed predicate devices (Lumenis, Inc. LightSheer® Pulsed Diode Array Laser System and AesThera Corporation AIP™ Intense Pulsed Light System). The FDA's letter confirms that the device is deemed "substantially equivalent" for the stated indications for use.

Conclusion based on the provided text:

This 510(k) summary does not present new acceptance criteria or the results of a primary study to prove new performance claims. Instead, it relies on the FDA's "substantial equivalence" pathway, meaning the device is considered safe and effective because it is comparable to devices already legally marketed. Therefore, the detailed questions about study design, sample sizes, and ground truth establishment for a novel performance study are not addressed in this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Lumenis. The logo consists of a stylized letter "L" inside of a circle, followed by the word "LUMENIS" in all capital letters. Below the company name is the tagline "Enhancing life. Advancing technology."

APR
K053628

510(k) Summary

Applicant:	Lumenis, Inc
Address:	2400 Condensa StreetSanta Clara, California 95051USA
Contact Person:	Connie HoyGlobal Director of Regulatory Affairsand Quality Assurance
Contact Numbers:	(408) 764-3303 Phone(408) 764-3500 Fax
Preparation Date:	December 28, 2005
Device Trade Name:	LightSheer® Duet™ Laser System
Common Name:	Pulsed Diode Array Laser
Classification Name:	Laser surgical instrument for use in General andPlastic Surgery and in Dermatology (see 21 CFR878.4810).Product Code: GEXPanel: 79
Legally-Marketed Predicate Device:	Lumenis, Inc. LightSheer® Pulsed Diode ArrayLaser System and AesThera Corporation AIP™

Intense Pulsed Light System.

Lomenis Inc. 2400 Condensa Street Santa Clara, CA 95051 USA t 408.764.3000 1 800.635.1313 1 408.764.3999 ww.lumenis.com

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K053628

System Description:

Intended Use of the Device:

LightSheer® Duet™ Laser Systems with LightSheer® HS™ Laser Handpiece is intended for the treatment of benign vascular and pigmented lesions, hair removal, and permanent hair reduction.

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s 36/i

Image /page/2/Picture/2 description: The image shows the Lumenis logo. The logo consists of a stylized letter "L" inside a circle on the left, followed by the word "LUMENIS" in a sans-serif font. Below the word "LUMENIS" is the tagline "Enhancing Life. Advancing technology."

Substantial Equivalence:

The specifications and indications for use of the LightSheer Duet Laser System are the same or very similar to those of the claimed pr dicate devices. The LightSheer Duet Laser System has the same or very similar indications for use for which the claimed predicates have been cleared. Based on the icregoing, the LightSheer Duet Laser System is substantially equivalent to the legally-1 1arketed claimed predicate devices for the purposes of this 510(k) submission.

Lumenis Inc. 2400 Condensa Street Santa Clara, CA 95051 DSA t 408.764.3000 1 800.635.131 3 1-408.764.3000 www.lumenis.com

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is written around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2006 APR

Lumenis, Inc. c/o Ms. Connie Hoy Global Director of Regulatory Affairs and Quality Assurance 2400 Condensa Street Santa Clara, California 95051

Re: K053628

Trade/Device Name: LightSheer® Duet™Laser System 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: March 1. 2006 Received: March 3, 2006

Dear Ms. Hoy:

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 cither 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

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Page 2 – Ms. Connie Hoy

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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Sincerely yours,

Mark N. Melkerson

Mark N. Melke 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): _ İC 5 14 20

Device Name: LightSheer® Duet™ Laser System

Indications for Use:

LightSheer® Duet™ Laser Systems with LightSheer® ET™ Laser Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The LightSheer® Duet™ Laser System with LightSheer® ET™ Laser Handpiece is also indicated for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins.

LightSheer® Duet™ Laser Systems with LightSheer® HS™ Laser Handpiece is indicated for the treatment of benign vascular and pigmented lesions, hair removal, and permanent hair reduction.

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)

eamoll

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

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510(k) Number_ Kos 3628

Lumenis 510(k) Submission: LightSheer Duet Laser System

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.