(25 days)
For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for a laser surgical instrument (New Star Lasers, Inc., Model 1320 Nd:YAG Surgical Laser, later referred to as NS-160). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar technological characteristics and is intended for the same use. The FDA therefore allows the device to be marketed.
Therefore, I cannot provide the requested information based on the provided text. The document is focused on regulatory approval based on substantial equivalence to a predicate device, not on presenting performance data from a specific study against predefined acceptance criteria.
§ 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.