(192 days)
Pulpotomy
Pulpotomy as an adjunct to root canal therapy
Pegasus Nd: YAG Laser System
This document is a 510(k) clearance letter for the Pegasus Nd:YAG Laser System. It does not contain information about acceptance criteria or a study proving device performance.
Therefore, I cannot provide the requested information. The letter only states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed for the specified indications for use. It does not include performance data, the details of any studies, or how ground truth was established for such studies.
§ 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.