510(k) K133740
K133740 is an FDA 510(k) premarket notification submitted by Sauflon Pharmaceuticals, Ltd. for the device "SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT". The FDA issued a decision of Substantially Equivalent on March 5, 2014. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Sauflon Pharmaceuticals, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 2014
- Date Received
- December 9, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lenses, Soft Contact, Daily Wear
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type