Cleared Traditional

Samfilcon B Custom Contact Lens

K230954 · Bausch & Lomb, Incorporated · Ophthalmic
Nov 2023
Decision
227d
Days
Class 2
Risk

About This 510(k) Submission

K230954 is an FDA 510(k) clearance for the Samfilcon B Custom Contact Lens, a Lenses, Soft Contact, Daily Wear (Class II — Special Controls, product code LPL), submitted by Bausch & Lomb, Incorporated (Rodchester, US). The FDA issued a Cleared decision on November 17, 2023, 227 days after receiving the submission on April 4, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K230954 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2023
Decision Date November 17, 2023
Days to Decision 227 days
Submission Type Traditional
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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