(71 days)
Used with a slit lamp adaptor, this system is indicated for use in retinal photocoagulation for the treatment of ophthalmic conditions including : Proliferative Diabetic Retinopathy, Macular Degeneration, and Retinal Detachment.
The laser source is an Nd: YAG Slab, pumped by a Laser Diode (810 nm), with a frequency doubling crystal (KTP).
The treatment beam is delivered through a delivery system and is aimed using a Red Laser Diode (670 nm).
The 3 possible delivery systems are the followirig :
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Slit lamp adaptor
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Indirect ophthalmoscope adaptor
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Endocular probe adaptor
Output power of all these delivery systems have a maximum of 1.5 Watts.
This document describes an ophthalmic laser device ("VIRIDIS" or "EVERGREEN 532") and compares it to predicate devices to demonstrate substantial equivalence. No acceptance criteria, device performance numbers, or details of a study proving the device meets acceptance criteria are provided in the extracted text. The document focuses on device description, intended use, and a comparison table of technical specifications with predicate devices.
Therefore, I cannot provide the requested information regarding acceptance criteria and the associated study. The provided text is a 510(k) summary, which typically focuses on demonstrating equivalence to legally marketed predicate devices rather than presenting detailed performance studies against pre-defined 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.