Cleared Traditional

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia

K210975 · Bausch & Lomb, Incorporated · Ophthalmic
May 2021
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K210975 is an FDA 510(k) clearance for the Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, 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 May 24, 2021, 53 days after receiving the submission on April 1, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5925.

Submission Details

510(k) Number K210975 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2021
Decision Date May 24, 2021
Days to Decision 53 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

Similar Devices — LPL Lenses, Soft Contact, Daily Wear

All 480
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
K252385 · Pegavision Corporation · Mar 2026
DAILIES TOTAL1?; DAILIES TOTAL1? Multifocal
K254052 · Alcon Laboratories, Inc. · Feb 2026
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)
K251683 · Bruno Vision Care, LLC · Dec 2025
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K250364 · St. shine Optical Co., Ltd. · Oct 2025
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear); Pure Plus UV Aspheric (Otufilcon A) 1-Day Silicone Soft (hydrophilic) Contact Lens (Daily Disposable)
K244009 · Yung Sheng Optical Co., Ltd. · Sep 2025
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
K251095 · Pegavision Corporation · Sep 2025

More from Bausch & Lomb, Incorporated

View all
EyeGility? Inserter for Preloaded enVista IOLs
K242389 · MSS · Oct 2024
Samfilcon B Custom Contact Lens
K230954 · LPL · Nov 2023
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
K220613 · LPL · Mar 2023
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
K222541 · LPN · Dec 2022
Independent Corneal Viewing Chamber (IVC-21)
K211786 · LYX · Dec 2021