Cleared Traditional

DISPOSABLE VITRECTOMY LENS

K012096 · Ocular Instruments, Inc. · Ophthalmic
Aug 2001
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K012096 is an FDA 510(k) clearance for the DISPOSABLE VITRECTOMY LENS, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by Ocular Instruments, Inc. (Bellevue, US). The FDA issued a Cleared decision on August 24, 2001, 50 days after receiving the submission on July 5, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K012096 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2001
Decision Date August 24, 2001
Days to Decision 50 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code HJK — Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1385

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