(332 days)
The YZ3 Portable Slit Lamp is intended for use in the examination of the anterior segment of the eye.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the YZ3 Portable Slit Lamp. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.
The 510(k) letter confirms that the device is substantially equivalent to legally marketed predicate devices for its intended use (examination of the anterior segment of the eye). It outlines regulatory compliance requirements but does not detail performance studies or testing results specifically.
Therefore, I cannot provide the requested information based on the input text.
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.