Cleared Special

Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal

K233856 · Alcon Laboratories, Inc. · Ophthalmic
Dec 2023
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K233856 is an FDA 510(k) clearance for the Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal, 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 December 29, 2023, 24 days after receiving the submission on December 5, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K233856 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2023
Decision Date December 29, 2023
Days to Decision 24 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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