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The ADVANTAGE Laser System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The ADVANTAGE Laser System is intended for use on all skin types (Fitzpatrick skin types I -VI), including tanned skin.

The ADVANTAGE Laser System with H1 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 ADVANTAGE Laser System with H1 Handpiece is also indicated for hair removal, permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9 and 12 months, and the treatment of benign pigmented lesions and leg veins.

The ADVANTAGE Laser System with H3 Handpiece is indicated for hair removal and permanent hair reduction defined as the long-term stable reduction in the number of hairs regrowing after the last treatment measured at 6, 9 and 12 months.

The ADVANTAGE Laser System is a non-invasive aesthetic laser. The system delivers pulsed infrared laser light with a wavelength ranging from 790-820 nm (805nm nominal) and has two treatment handpieces. The ADVANTAGE HI handpiece delivers laser energy through a 10 x 10mm tip with a fluence of up to 100 J/cm². The settings for this handpiece are selectable pulse duration from 5 ~ 400ms. selectable fluence from 5 ~ 1001/cm² and a pulse repetition rate up to 3 Hz maximum. A second handniece, the ADVANTAGE H3 handpiece, delivers laser energy through a 10 x 30mm tip, with a fluence of up to 35 J/cm². The settings for this handpiece are pulse duration from 30 ~ 400ms, and a pulse repetition rate up to 2 Hz maximum. The complete system consists of a console and handbiece connected to the system cable. 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 physician is able to control the settings of laser energy from the LCD display on the main console.

This document is a 510(k) summary for the Lutronic Corporation ADVANTAGE Laser System, requesting clearance to market. It explicitly states in section 7, "Performance Data: None presented."

Therefore, based on the provided text, the following information cannot be extracted:

1. Table of acceptance criteria and reported device performance: No performance data or acceptance criteria are provided.
2. Sample size used for the test set and the data provenance: No test data was presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test data was presented, thus no ground truth establishment is described.
4. Adjudication method: No test data was presented.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
6. Standalone (algorithm only) performance: This device is a laser system, not an AI algorithm, so this question is not applicable.
7. Type of ground truth used: No test data was presented.
8. Sample size for the training set: No training data was presented.
9. How the ground truth for the training set was established: No training data was presented.

The 510(k) submission relies on demonstrating substantial equivalence to a predicate device (Lumenis LightSheer Duet Laser System) based on similar intended use and technological characteristics, rather than new performance data.

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