Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker
FDA 510(k) K130342 · Sauflon Pharmaceuticals, Ltd.
510(k) numberK130342
Submission
- Device name
- Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker
- Applicant
- Sauflon Pharmaceuticals, Ltd.
Twickenham, Middlesex, GB - Received
- February 11, 2013
- Decision date
- August 5, 2013
- 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 |
|---|---|---|
| K133740 | Sauflon Clariti with Tint, Sauflon Clariti Toric with Tint, Sauflon Clariti Multifocal…LPL · Traditional | 03/05/2014SE |
| K130331 | Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens…MVN · Traditional | 07/26/2013SE |
| K130734 | Sauflon Multipurpose SolutionLPN · Traditional | 05/15/2013SE |
| K052832 | Sauflon New Day (Methafilcon a) Soft (Hydrophilic) Daily Disposable Contact LensesMVN · Traditional | 05/15/2006SE |
| K052809 | Sauflon Flat Coloured Lens CaseLRX · Traditional | 11/02/2005SE |
| K033656 | Sauflon Flat Lens Case/Sauflon 2003 Barrel Lens CaseLRX · Traditional | 02/02/2004SE |
| K030278 | Sauflon Multipurpose Solution - No RubLPN · Traditional | 07/30/2003SE |
| K013649 | Sauflon 55 UV Soft (Hydrophilic) Contact LensLPL · Traditional | 12/26/2001SE |
| K010559 | Sauflon Multi Lens Care SystemLPN · Traditional | 12/20/2001SE |
| K011456 | Delta Plus Multiaction Solution for Rigid Gas Permeable Contact LensesMRC · Traditional | 07/17/2001SE |
Questions and answers
When was Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker cleared by the FDA?
Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker (K130342) received a 510(k) decision of Substantially Equivalent on August 5, 2013, 175 days after the submission was received.
What is the product code of K130342?
The FDA product code is LPL – Lenses, Soft Contact, Daily Wear, a Class II (moderate risk) device regulated under 21 CFR 886.5925.