(259 days)
The MediWorks Model S series Slit Lamps are AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. They are used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.
AC-powered slit lamp biomicroscopes
I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA to Shanghai Mediworks Precision Instruments Co., Ltd. for a Slit Lamp Microscope. This document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, or study details. It primarily focuses on the FDA's determination of substantial equivalence to a predicate device and regulatory requirements. Therefore, I cannot fulfill your request based on the given input.
§ 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.