Cleared Traditional

OMS SLIMLINE PHACO HANDPIECE

K950218 · Optical Micro Systems, Inc. · Ophthalmic
Jul 1995
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K950218 is an FDA 510(k) clearance for the OMS SLIMLINE PHACO HANDPIECE, 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 17, 1995, 179 days after receiving the submission on January 19, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K950218 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 1995
Decision Date July 17, 1995
Days to Decision 179 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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

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