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K Number
K012096
Device Name
DISPOSABLE VITRECTOMY LENS
Manufacturer
OCULAR INSTRUMENTS, INC.
Date Cleared
2001-08-24

(50 days)

Product Code
HJK
Regulation Number
886.1385
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Allow visualization of the ocular fundus, vitreous, and retinal structures during vitrectomy surgery.

Device Description

Disposable Vitrectomy Lens

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a Disposable Vitrectomy Lens. It does not contain information about acceptance criteria or a study proving the device meets them. The letter simply states that the FDA has reviewed the 510(k) notification and found the device to be substantially equivalent to devices marketed prior to May 28, 1976.

Therefore, I cannot provide the requested information from the provided text. The document is an approval letter, not a study report.

§ 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.