(224 days)
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.
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.
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, |
§ 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.