Cleared Traditional

MAINSTER WIDE FIELD LASER LENS

K896198 · Ocular Instruments, Inc. · Ophthalmic
Dec 1989
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K896198 is an FDA 510(k) clearance for the MAINSTER WIDE FIELD 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 December 18, 1989, 52 days after receiving the submission on October 27, 1989. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K896198 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 1989
Decision Date December 18, 1989
Days to Decision 52 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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