(435 days)
The Microruptor 6 Nd: Y AG Laser is indicated for:
-
posterior capsulotomy,
-
pupillary membranectomy
-
peripheral iridotomy
Microruptor 6 Nd: YAG Laser
I am sorry but this document does not contain the information you are requesting. The document is an FDA 510(k) clearance letter for the Microruptor 6 Nd: YAG Laser, which indicates the device has been found substantially equivalent to a predicate device. It specifies the indications for use but does not include details on acceptance criteria and a study proving the device meets those criteria, or any information about AI algorithms.
§ 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.