Cleared Traditional

QUADRASPHERIC FUNDUS LENS

K943125 · Volk Optical, Inc. · Ophthalmic
Sep 1994
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K943125 is an FDA 510(k) clearance for the QUADRASPHERIC FUNDUS LENS, a Lens, Contact, Polymethylmethacrylate, Diagnostic (Class II — Special Controls, product code HJK), submitted by Volk Optical, Inc. (Cleveland, US). The FDA issued a Cleared decision on September 2, 1994, 65 days after receiving the submission on June 29, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1385.

Submission Details

510(k) Number K943125 FDA.gov
FDA Decision Cleared SESE
Date Received June 29, 1994
Decision Date September 02, 1994
Days to Decision 65 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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