Sauflon New Day (Methafilcon a) Soft (Hydrophilic) Daily Disposable Contact Lenses
FDA 510(k) K052832 · Sauflon Pharmaceuticals, Ltd.
510(k) numberK052832
Submission
- Device name
- Sauflon New Day (Methafilcon a) Soft (Hydrophilic) Daily Disposable Contact Lenses
- Applicant
- Sauflon Pharmaceuticals, Ltd.
Twickenham, Middlesex, GB - Received
- October 6, 2005
- Decision date
- May 15, 2006
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K130331 | Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens…MVN · Traditional | Sauflon Pharmaceuticals, Ltd. | 07/26/2013SE |
| 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 |
More from Innova Vision, 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 |
| 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 |
| 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 New Day (Methafilcon a) Soft (Hydrophilic) Daily Disposable Contact Lenses cleared by the FDA?
Sauflon New Day (Methafilcon a) Soft (Hydrophilic) Daily Disposable Contact Lenses (K052832) received a 510(k) decision of Substantially Equivalent on May 15, 2006, 221 days after the submission was received.
What is the product code of K052832?
The FDA product code is MVN – Lens, Contact, (Disposable), a Class II (moderate risk) device regulated under 21 CFR 886.5925.