SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES— 510(k) K991125
Substantially EquivalentSauflon Pharmaceuticals, Ltd.
FDA 510(k) clearance K991125 for SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES, Substantially Equivalent on 1999-09-14. 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
- Chicago, IL, US
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
- K130734 — SAUFLON MULTIPURPOSE SOLUTION
- K052832 — SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSES
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.