510(k) K001620
METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN by
Metro Optics of Austin, Inc.
— Product Code LPL
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 13, 2000
- Date Received
- May 25, 2000
- 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