510(k) K122575
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI by
Bausch & Lomb, Inc.
— Product Code LPL
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 20, 2012
- Date Received
- August 23, 2012
- 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