510(k) K091339
K091339 is an FDA 510(k) premarket notification submitted by CooperVision, Inc. for the device "BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS". The FDA issued a decision of Substantially Equivalent on January 5, 2010. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. CooperVision, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 2010
- Date Received
- May 6, 2009
- 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