510(k) K123202 ยท LPL Lenses, Soft Contact, Daily Wear
PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS
| Applicant | CooperVision, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, May 30, 2013 |
| Received | Oct 12, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K123202
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2014 | Cooper Vision Caribbean Corp. ProClear Toric contact lenses are made from a material containing 62% water and 38% omafilcon B, a random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid. The lenses have a tint ( Terminated |
LPL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.