(119 days)
The ND: YAG Laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, Nevus, 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.
The device 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. It is for prescription use only.
This document is a 510(k) Pre-market Notification for a medical device called the "ND:YAG Laser" (Model SL-NY602) from Beijing Superlaser Technology Co., Ltd. It seeks to demonstrate substantial equivalence to a predicate device, the "ND YAG Q-switch Laser Therapy Machine" (K161926) from Beijing ADSS Development Co., Ltd.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
Strictly speaking, this document does not present "acceptance criteria" in the traditional sense of specific performance metrics with defined thresholds for sensitivity, specificity, accuracy, etc. Instead, it aims to demonstrate substantial equivalence (SE) based on comparative tables for general, technical, and safety aspects. The "acceptance criteria" for this type of submission are that the proposed device is as safe and effective as the predicate device. The reported performance is implicitly the device meeting the described characteristics.
| Criterion/Metric | Predicated Device K161926 Performance (Implied Acceptance) | Proposed Device ND:YAG Laser Performance | Remark |
|---|---|---|---|
| General | |||
| Product Code | GEX | GEX | SE |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | 2 | 2 | SE |
| Where used | hospital | hospital | SE |
| Intended Use | Treatment of benign cutaneous lesions (Warts, Scars, Striae, Psoriasis), benign pigmented lesions (Lentigines, Nevus, Birthmark), and removal of black or blue tattoos. | Treatment of benign cutaneous lesions (Warts, Scars, Striae, Psoriasis), benign pigmented lesions (Lentigines, Nevus, Birthmark), and removal of black or blue tattoos. | SE |
| Technical | |||
| Laser Medium | Nd:YAG | Nd:YAG | SAME |
| Wavelength | 1064 nm, 532 nm | 1064 nm, 532 nm | SAME |
| Output energy | 100-1000mJ (1064nm), 50-500mJ (532nm) | 100-1000mJ (1064nm), 50-500mJ (532nm) | SAME |
| Max. Energy Density | 31.8J/cm2, 15.9 J/cm2 | 31.8J/cm2, 15.9 J/cm2 | SAME |
| Spot Size | 2-10mm | 2-10mm | SAME |
| Pulse Width | 5ns-8ns | 5ns-8ns | DIFFERENT |
| Frequency | 1-10 Hz | 1-10 Hz | SAME |
| Disinfection | Disinfect handpiece by 75% medicinal alcohol | Wipe outer surface with 70% alcohol and non-abrasive medical grade anti-bacterial | SIMILAR (both relate to cleaning/disinfection methods for safety) |
| Laser Class | Class 4 | Class 4 | SAME |
| Aiming Beam | 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.