Cleared Traditional

MAINSTER HIGH MAGNIFICATION LASER LENS

K912366 · Ocular Instruments, Inc. · Ophthalmic
Jun 1991
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K912366 is an FDA 510(k) clearance for the MAINSTER HIGH MAGNIFICATION 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 June 25, 1991, 27 days after receiving the submission on May 29, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K912366 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1991
Decision Date June 25, 1991
Days to Decision 27 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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