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The ND YAG Q-switch Laser Therapy Machine is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.

Device Description

The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm.

There are 3 models included, FG 2010, FG 2010-B, FG 2010-C, the three models have same intended use, mechanism of action, principle and specification, only differences are the configurations.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel acceptance criteria or comprehensive study results for a new AI/software system. Therefore, much of the requested information regarding AI-specific criteria, studies, and ground truth establishment is not applicable or available in this document.

However, I can extract the relevant information from the provided text as it pertains to the device's performance claims and the studies conducted to support its substantial equivalence.

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

The document does not explicitly state acceptance criteria in the typical sense for a new AI/software device. Instead, it compares the proposed device's specifications and performance to a predicate device to demonstrate "substantial equivalence" (SE). The "reported device performance" is essentially the detailed specifications of the proposed device as presented for comparison.

Criterion Type	Acceptance Criteria (Predicate Device K072536)	Reported Device Performance (Proposed Device)	Remark
Regulatory Information
Product Code	GEX	GEX	SE
Regulation No.	21 CFR 878.4810	21 CFR 878.4810	SE
Class	2	2	SE
Intended Use	Benign cutaneous lesions, benign pigmented lesions, tattoo removal, vascular lesions, non-ablative treatment of facial wrinkles, laser skin resurfacing, reduction of red pigmentation in scars, use on all skin types.	Benign cutaneous lesions (Warts, Scars, Striae, Psoriasis); benign pigmented lesions (Lentigines, nevus, birthmark); removal of black or blue tattoos.	SE
Performance Comparison
Laser Medium	Nd:YAG	Nd:YAG	SE
Wavelength	1064 nm, 532 nm	1064 nm, 532 nm	SE
Output energy	400-1200mJ	100-1000mJ for 1064nm, 50-500mJ for 532nm	SE
Max. Energy Density	16.9 J/cm²	31.8 J/cm² (for 1064nm), 15.9 J/cm² (for 532nm)	Analysis
Spot Size	3, 5 mm	2-10mm	Analysis
Pulse Width	20 ns	5ns-8ns	Analysis
Repetition Rate	1, 2, 4 Hz	1-10 Hz	Analysis
Disinfection	---	Disinfect the handpiece before and after every treatment by 75% medicinal alcohol	Analysis
Laser Class	Class 4	Class 4	SE
Cooling method for treated skin	N.A.	N.A.	SE
Aiming Beam	N.A.	Red Laser,

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