(86 days)
The indications for use for the above product family is:
- Iridectomy/Iridotomy.
- Posterior Capsulotomy.
- Posterior Membranectomies.
Not Found
I'm sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Laserex Q-S/W Nd:YAG Lasers). It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt regarding a study that proves the device meets acceptance criteria.
The letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance, not necessarily a demonstration of meeting specific performance acceptance criteria through a clinical or technical study as you've outlined.
Therefore, I cannot provide the requested information based on the given 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.