The following data is part of a premarket notification filed by Sauflon Pharmaceuticals, Ltd. with the FDA for Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens With Uv Blocker.
| Device ID | K130331 |
| 510k Number | K130331 |
| Device Name: | SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER |
| Classification | Lens, Contact, (disposable) |
| Applicant | SAUFLON PHARMACEUTICALS, LTD. 49-53 YORK ST. Twickenham, Middlesex, GB Tw1-3lp |
| Contact | Christopher Smejkal |
| Correspondent | Christopher Smejkal SAUFLON PHARMACEUTICALS, LTD. 49-53 YORK ST. Twickenham, Middlesex, GB Tw1-3lp |
| Product Code | MVN |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-11 |
| Decision Date | 2013-07-26 |
| Summary: | summary |