Cleared Traditional

AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM

K951462 · Allergan Medical Optics · Ophthalmic
Jun 1995
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K951462 is an FDA 510(k) clearance for the AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by Allergan Medical Optics (Irvine, US). The FDA issued a Cleared decision on June 15, 1995, 77 days after receiving the submission on March 30, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K951462 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 1995
Decision Date June 15, 1995
Days to Decision 77 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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