510(k) K071736 ยท LPL Lenses, Soft Contact, Daily Wear
AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
| Applicant | CooperVision, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Jan 4, 2008 |
| Received | Jun 26, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071736
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Coopervision Inc. AVAIRA AQUAFORM Comfort Science enfilcon A Daily Wear SPHERE Soft Contact Lenses (disposable), Rx only, STERILE --- CooperVision: Hamble, SO31 4RF, UK -- Scottsville, NY 14546 USA -- Juana Diaz, PR 00 Terminated |
LPL | None listed |
| Oct 14, 2011 | CooperVision Inc. AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 SOFT CONTACT LENSES FOR ASTIGMATISM, CooperVision, Scottsville, NY 14546 USA; Juana Diaz, PR 00795 USA; Hamble SO31, 4RF, UK; Devi Terminated |
LPL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.