(73 days)
The Norlase LYNX Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty.
Not Found
I apologize, but the provided text from the FDA 510(k) clearance letter for the LYNX Photocoagulator does not contain information on the acceptance criteria and the study that proves the device meets those criteria.
This document is a clearance letter, which confirms that the FDA has found the device to be substantially equivalent to a legally marketed predicate device. It briefly touches on device classification, regulations, and mentions the intended use of the device.
To describe the acceptance criteria and the study that proves the device meets them, I would need access to the actual 510(k) submission summary or a more detailed technical report which would typically include sections on performance testing, design specifications, and clinical or non-clinical data. The provided document only details the regulatory clearance, not the underlying performance data.
Therefore, I cannot fulfill your request with the given input.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.