Cleared Traditional

PIEZO HANDPIECE

K902150 · United Surgical Corp. · Ophthalmic
Jul 1990
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K902150 is an FDA 510(k) clearance for the PIEZO HANDPIECE, a Unit, Phacofragmentation (Class II — Special Controls, product code HQC), submitted by United Surgical Corp. (Irvine, US). The FDA issued a Cleared decision on July 5, 1990, 51 days after receiving the submission on May 15, 1990. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number K902150 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1990
Decision Date July 05, 1990
Days to Decision 51 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

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

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