Cleared Traditional

AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38

K925254 · Allergan Medical Optics · Ophthalmic
Jan 1993
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K925254 is an FDA 510(k) clearance for the AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Allergan Medical Optics (Anasco, US). The FDA issued a Cleared decision on January 7, 1993, 80 days after receiving the submission on October 19, 1992. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K925254 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1992
Decision Date January 07, 1993
Days to Decision 80 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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