Cleared Traditional

OPTI-ONE MULTI-PURPOSE SOLUTION

K983973 · Alcon Laboratories · Ophthalmic
Dec 1998
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K983973 is an FDA 510(k) clearance for the OPTI-ONE MULTI-PURPOSE SOLUTION, 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 December 18, 1998, 39 days after receiving the submission on November 9, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K983973 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1998
Decision Date December 18, 1998
Days to Decision 39 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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