Sauflon Multipurpose Solution
FDA 510(k) K130734 · Sauflon Pharmaceuticals, Ltd.
510(k) numberK130734
Submission
- Device name
- Sauflon Multipurpose Solution
- Applicant
- Sauflon Pharmaceuticals, Ltd.
Twickenham, Middlesex, GB - Received
- March 18, 2013
- Decision date
- May 15, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPN – Accessories, Soft Lens Products
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5928
- Specialty
- Ophthalmic
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| K210051 | OTE MPS 045 Multi-purpose Lens Care SolutionLPN · Traditional | Ote North America, LLC | 05/26/2021SE |
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| K200747 | PuriLens Plus Preservative Free SalineLPN · Traditional | The Lifestyle Company, Inc. | 05/15/2020SE |
| K191872 | Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting SolutionLPN · Traditional | Menicon Co, Ltd. | 03/02/2020SE |
| K190674 | REFRESH RELIEVA For CONTACTSLPN · Traditional | Allergan, Inc. | 08/08/2019SE |
| K191795 | AOCup Lens Case with AODiscLPN · Special | Alcon Laboratories, Inc. | 07/31/2019SE |
More from Alcon Laboratories, 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 |
| 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 Multipurpose Solution cleared by the FDA?
Sauflon Multipurpose Solution (K130734) received a 510(k) decision of Substantially Equivalent on May 15, 2013, 58 days after the submission was received.
What is the product code of K130734?
The FDA product code is LPN – Accessories, Soft Lens Products, a Class II (moderate risk) device regulated under 21 CFR 886.5928.