Cleared Traditional

DIPLOMAX

K946054 · Optical Micro Systems, Inc. · Ophthalmic
Jul 1995
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K946054 is an FDA 510(k) clearance for the DIPLOMAX, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Optical Micro Systems, Inc. (North Andover, US). The FDA issued a Cleared decision on July 11, 1995, 211 days after receiving the submission on December 12, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K946054 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1994
Decision Date July 11, 1995
Days to Decision 211 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQC — Unit, Phacofragmentation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4670

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