Cleared Traditional

P4000 PHACOEMULSIFIER

K931354 · American Optical Corp. · Ophthalmic
Feb 1994
Decision
342d
Days
Class 2
Risk

About This 510(k) Submission

K931354 is an FDA 510(k) clearance for the P4000 PHACOEMULSIFIER, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by American Optical Corp. (Irvine, US). The FDA issued a Cleared decision on February 22, 1994, 342 days after receiving the submission on March 17, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K931354 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1993
Decision Date February 22, 1994
Days to Decision 342 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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