Cleared Special

Precision1, Precision1 for Astigmatism

K230785 · Alcon Laboratories, Inc. · Ophthalmic
Apr 2023
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K230785 is an FDA 510(k) clearance for the Precision1, Precision1 for Astigmatism, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on April 20, 2023, 29 days after receiving the submission on March 22, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K230785 FDA.gov
FDA Decision Cleared SESE
Date Received March 22, 2023
Decision Date April 20, 2023
Days to Decision 29 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPL — Lenses, Soft Contact, Daily Wear
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5925

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