(60 days)
The Vitrectomy Lenses are intended to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures. Vitrectomy lenses are indicated for use during vitreoretinal surgical procedures.
D.O.R.C. Vitrectomy Lens includes a variety of designs both sterile, single use, disposable vitrectomy lenses, as well as vitrectomy lenses intended to be reused which are sold non-sterile.
This document is a 510(k) summary for the D.O.R.C. Vitrectomy Lens, indicating that it has been found substantially equivalent to a predicate device. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The provided text is a regulatory filing, not a scientific study report.
Therefore, I cannot provide the requested information from the text. The document focuses on regulatory approval based on substantial equivalence, not on performance metrics against predefined acceptance criteria.
§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.