Cleared Traditional

K021566 - INFINITI (FDA 510(k) Clearance)

K021566 · Alcon Laboratories, Inc. · Ophthalmic device

Jul 2002

Decision

50d

Days

Class 2

Risk

K021566 is an FDA 510(k) clearance for the INFINITI. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).

Submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on July 2, 2002, 50 days after receiving the submission on May 13, 2002.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.

Submission Details

510(k) Number	K021566 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 13, 2002
Decision Date	July 02, 2002
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF