(91 days)
The Vivid Light™ LED lamps for slit lamp biomicroscope are intended to be used as accessories for replacement of the 6V Tungsten bulb for Haag Streit's BM900, BQ900, BX900 and BP900 slit lamp biomicroscopes. Haag Streit's slit lamp biomicroscopes are indicated as noninvasive aid to the examination and diagnosis of eye conditions and in fitting of contact lenses.
Vivid Light™ LED lamps for slit lamp biomicroscope
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§ 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.