FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
K Number: K130331
·
Decision Jul 26, 2013
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
24
Applicant Total
12
Review Days
165
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Basic Information
- Device Name
- SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
- K Number
- K130331
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.5925
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sauflon Pharmaceuticals, Ltd.
- Date Received
- February 11, 2013
- Decision Date
- July 26, 2013
- Product Code
- MVN
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MVN | Lens, Contact, (Disposable) | FDA class 2 | Ophthalmic |
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Other Clearances by Sauflon Pharmaceuticals, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K133740 | SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT | Mar 5, 2014 | Substantially Equivalent |
| K130342 | SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER | Aug 5, 2013 | Substantially Equivalent |
| K130734 | SAUFLON MULTIPURPOSE SOLUTION | May 15, 2013 | Substantially Equivalent |
| K052832 | SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES | May 15, 2006 | Substantially Equivalent |
| K052809 | SAUFLON FLAT COLOURED LENS CASE | Nov 2, 2005 | Substantially Equivalent |
| K033656 | SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE | Feb 2, 2004 | Substantially Equivalent |
| K030278 | SAUFLON MULTIPURPOSE SOLUTION - NO RUB | Jul 30, 2003 | Substantially Equivalent |
| K013649 | SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS | Dec 26, 2001 | Substantially Equivalent |
| K010559 | SAUFLON MULTI LENS CARE SYSTEM | Dec 20, 2001 | Substantially Equivalent |
| K011456 | DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES | Jul 17, 2001 | Substantially Equivalent |