(42 days)
The Eyesys Uista has the Same intended use as other analysis and topography sustems. It specifically measures, records, and corneal arolyzes corneal curvature in a non-invasive manner.
The EyeSys Vista will be operated by dostors and technicians in ophtholmic and optometric offices . Corners topogital pho for potient screening become the standard of care documentation, corneal operative corneal surgery portu defermination and follow- up, as well as assisting in the and follow-up lenses. of contact
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This appears to be an FDA 510(k) clearance letter from 1997 for the "Eye Sys Vista TM" device. This document primarily focuses on regulatory clearance and substantial equivalence.
Therefore, the provided text does not contain the information requested about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details. These types of details are typically found in the 510(k) summary or the full 510(k) submission, not in the clearance letter itself.
§ 886.1350 Keratoscope.
(a)
Identification. A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.(b) The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files