SAUFLON MULTIPURPOSE SOLUTION— 510(k) K130734
Substantially EquivalentSauflon Pharmaceuticals, Ltd.
FDA 510(k) clearance K130734 for SAUFLON MULTIPURPOSE SOLUTION, Substantially Equivalent on 2013-05-15. Applicant: Sauflon Pharmaceuticals, Ltd.. Device class: 2.
Clearance details
- Applicant
- Sauflon Pharmaceuticals, Ltd.
- Product code
- Code LPN
- Device class
- Class 2
- Regulation
- 21 CFR 886.5928
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Twickenham, Middlesex, GB
Recent devices under product code LPN
view allMore clearances from Sauflon Pharmaceuticals, Ltd.
view all- K133740 — SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT
- K130342 — SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER
- K130331 — SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKER
- K052832 — SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES
- K052809 — SAUFLON FLAT COLOURED LENS CASE
Adverse events under product code LPN
product code LPN- Injury
- 333
- Other
- 8
- Total
- 341
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.