Cleared Traditional

OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER

K990480 · Alcon Laboratories · Ophthalmic
May 1999
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K990480 is an FDA 510(k) clearance for the OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on May 10, 1999, 83 days after receiving the submission on February 16, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K990480 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 1999
Decision Date May 10, 1999
Days to Decision 83 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPN — Accessories, Soft Lens Products
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5928

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