Cleared Traditional

BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE

K801659 · Coburn Optical Ind., Inc. · Ophthalmic
Sep 1980
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K801659 is an FDA 510(k) clearance for the BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE, a Biomicroscope, Slit-lamp, Ac-powered (Class II — Special Controls, product code HJO), submitted by Coburn Optical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980, 50 days after receiving the submission on July 21, 1980. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1850.

Submission Details

510(k) Number K801659 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1980
Decision Date September 09, 1980
Days to Decision 50 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HJO — Biomicroscope, Slit-lamp, Ac-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.1850

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