SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS— 510(k) K013649
Substantially EquivalentSauflon Pharmaceuticals, Ltd.
FDA 510(k) clearance K013649 for SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS, Substantially Equivalent on 2001-12-26. Applicant: Sauflon Pharmaceuticals, Ltd.. Device class: 2.
Clearance details
- Applicant
- Sauflon Pharmaceuticals, Ltd.
- Product code
- Product code LPL
- Device class
- Class 2
- Regulation
- 21 CFR 886.5925
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Twickenham, Middlesex, GB
Recent devices under product code LPL
view all- K260311 — Saview 60 UV (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
- K253875 — OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens +2 more
- K262941 — Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens
- K262495 — Miru 1day UpSide (midafilcon A)
- K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
More 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 LPL
product code LPL- Injury
- 988
- Other
- 4
- Total
- 992
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.