Cleared Traditional

NMR-K FUNDUS LASER LENS

K910231 · Ocular Instruments, Inc. · Ophthalmic
Jan 1991
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K910231 is an FDA 510(k) clearance for the NMR-K FUNDUS LASER 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 January 28, 1991, 10 days after receiving the submission on January 18, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K910231 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 1991
Decision Date January 28, 1991
Days to Decision 10 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

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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