Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)
FDA 510(k) K202756 · CooperVision, Inc.
510(k) numberK202756
Submission
- Device name
- Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)
- Applicant
- CooperVision, Inc.
San Ramon, CA, US - Received
- September 21, 2020
- Decision date
- October 20, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact…LPL · Special | 01/25/2024SE |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality…LPL · Special | 02/04/2022SE |
| K213164 | Avaira VitalityLPL · Special | 10/26/2021SE |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…LPL · Traditional | 03/23/2020SE |
| K190965 | MyDayLPL · Special | 04/29/2019SE |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV…LPL · Traditional | 12/11/2018SE |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensLPL · Traditional | 07/13/2016SE |
| K133627 | Avaira Spheric and Toric (Enfilcon a) Soft Contact LensLPL · Special | 12/23/2013SE |
| K131378 | Sus (Stenfilcon a) Contact LensLPL · Traditional | 08/30/2013SE |
| K123202 | Proclear (Omafilcon a) Soft Hydrophilic) Contact LensLPL · Special | 05/30/2013SE |
Questions and answers
When was Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) cleared by the FDA?
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) (K202756) received a 510(k) decision of Substantially Equivalent on October 20, 2020, 29 days after the submission was received.
What is the product code of K202756?
The FDA product code is LPL – Lenses, Soft Contact, Daily Wear, a Class II (moderate risk) device regulated under 21 CFR 886.5925.