(42 days)
Light source for the purpose of curing light activated dental composites and activating dental bleaching agents.
Not Found
The provided text is an FDA 510(k) clearance letter for a device named PULSTAR™. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The letter is a regulatory document confirming that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. It does not include the technical details of the device's validation or verification.
Therefore, I cannot provide the requested information based on the input text.
§ 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.