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
FDA 510(k) K220613 · Bausch & Lomb, Incorporated
510(k) numberK220613
Submission
- Device name
- 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
- Applicant
- Bausch & Lomb, Incorporated
Rochester, NY, US - Received
- March 3, 2022
- Decision date
- March 8, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPL – Lenses, Soft Contact, Daily Wear
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5925
- Specialty
- Ophthalmic
Other 510(k)s with product code LPL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260507 | Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo…LPL · Traditional | INTEROJO, Inc. | 05/29/2026SE |
| K253352 | Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Traditional | Pegavision Corporation | 05/21/2026SE |
| K261299 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Special | Pegavision Corporation | 05/19/2026SE |
| K253885 | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON…LPL · Traditional | Geo Medical Co., Ltd. | 04/29/2026SE |
| K254269 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional | St. shine Optical Co., Ltd. | 03/19/2026SE |
| K252385 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Traditional | Pegavision Corporation | 03/13/2026SE |
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalLPL · Traditional | Alcon Laboratories, Inc. | 02/13/2026SE |
| K251683 | Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking…LPL · Traditional | Bruno Vision Care, LLC | 12/23/2025SE |
| K250364 | Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional | St. shine Optical Co., Ltd. | 10/07/2025SE |
| K244009 | Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…LPL · Traditional | Yung Sheng Optical Co., Ltd. | 09/25/2025SE |
More from Yung Sheng Optical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K242389 | EyeGility Inserter for Preloaded enVista IOLsMSS · Traditional | 10/10/2024SE |
| K222541 | Bausch + Lomb Preservative Free Lubricating and Rewetting DropsLPN · Traditional | 12/06/2022SE |
| K202932 | ABT12 multi-purpose solutionLPN · Traditional | 05/28/2021SE |
| K210975 | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for PresbyopiaLPL · Traditional | 05/24/2021SE |
| K200416 | Boston One Step Liquid Enzymatic CleanerMRC · Traditional | 09/23/2020SE |
| K192005 | Bausch + Lomb PreVue Inserter for enVista PreloadedMSS · Special | 10/04/2019SE |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)…HQD · Traditional | 02/12/2019SE |
| K182249 | Ultra (samfilcon A) Multifocal for Astigmatism Contact LensLPL · Traditional | 11/30/2018SE |
| K181627 | Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid…MRC · Traditional | 08/10/2018SE |
| K173480 | Crystalsert Lens Delivery SystemMSS · Special | 12/11/2017SE |
Questions and answers
When was 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 cleared by the FDA?
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) received a 510(k) decision of Substantially Equivalent on March 8, 2023, 370 days after the submission was received.
What is the product code of K220613?
The FDA product code is LPL – Lenses, Soft Contact, Daily Wear, a Class II (moderate risk) device regulated under 21 CFR 886.5925.