Sauflon 55 UV Soft (Hydrophilic) Contact Lens
FDA 510(k) K013649 · Sauflon Pharmaceuticals, Ltd.
510(k) numberK013649
Submission
- Device name
- Sauflon 55 UV Soft (Hydrophilic) Contact Lens
- Applicant
- Sauflon Pharmaceuticals, Ltd.
Twickenham, Middlesex, GB - Received
- November 5, 2001
- Decision date
- December 26, 2001
- 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 |
| K130342 | Sauflon Clariti (Somofilcon a) Soft (Hydrophilic) Contact Lens with UV BlockerLPL · Traditional | 08/05/2013SE |
| 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 |
| 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 55 UV Soft (Hydrophilic) Contact Lens cleared by the FDA?
Sauflon 55 UV Soft (Hydrophilic) Contact Lens (K013649) received a 510(k) decision of Substantially Equivalent on December 26, 2001, 51 days after the submission was received.
What is the product code of K013649?
The FDA product code is LPL – Lenses, Soft Contact, Daily Wear, a Class II (moderate risk) device regulated under 21 CFR 886.5925.