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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.

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.

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.

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