510(k) K973063 ยท LPL Lenses, Soft Contact, Daily Wear
FREQUENCY 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR
| Applicant | Aspect Vision Care, Ltd., Freehold NJ, US |
| Decision | Substantially Equivalent, Aug 26, 1997 |
| Received | Aug 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973063
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 3, 2003 | Coopervision Inc SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A)
and (2) ONEVUE 55 toric (methafilcon A) flexible wear.
Responsible firm on label: Coopervision, Terminated |
LPL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.