Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
FDA 510(k) K130331 · Sauflon Pharmaceuticals, Ltd.
510(k) numberK130331
Submission
- Device name
- Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
- Applicant
- Sauflon Pharmaceuticals, Ltd.
Twickenham, Middlesex, GB - Received
- February 11, 2013
- Decision date
- July 26, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MVN – Lens, Contact, (Disposable)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5925
- Specialty
- Ophthalmic
Other 510(k)s with product code MVN
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|---|---|---|---|
| K261812 | HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina…MVN · Special | HOYA Lamphun , Ltd. | 07/07/2026SE |
| K202448 | DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP MultifocalMVN · Special | Alcon Laboratories, Inc. | 09/22/2020SE |
| K202036 | Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort…MVN · Special | Alcon Laboratories, Inc. | 08/21/2020SE |
| K150630 | Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear…MVN · Traditional | Yung Sheng Optical Co., Ltd. | 06/15/2015SE |
| K143190 | Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact LensMVN · Traditional | Yung Sheng Optical Co., Ltd. | 01/16/2015SE |
| K112192 | Naturelle Daily Disposable (Hilafilcon B) Cosmetically Tinted Contact LensMVN · Special | Bausch & Lomb, Inc. | 10/25/2011SE |
| K080632 | CLEAR1-DAY Hioxifilcon Daily Disposable Soft Contact LensMVN · Traditional | Clearlab SG Pte, Ltd. | 10/15/2008SE |
| K080755 | Soflens Daily Disposable Toric (Hilafilcon B) Visibility Tinted Contact LensMVN · Traditional | Bausch & Lomb, Inc. | 06/10/2008SE |
| K073060 | Calaview (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearMVN · Special | Innova Vision, Inc. | 11/29/2007SE |
| K061948 | Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensMVN · Traditional | CooperVision, Inc. | 11/22/2006SE |
More from CooperVision, Inc.
| 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 |
| 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 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker cleared by the FDA?
Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker (K130331) received a 510(k) decision of Substantially Equivalent on July 26, 2013, 165 days after the submission was received.
What is the product code of K130331?
The FDA product code is MVN – Lens, Contact, (Disposable), a Class II (moderate risk) device regulated under 21 CFR 886.5925.