510(k) K102557 ยท LPL Lenses, Soft Contact, Daily Wear
NOVAKONE SPHERICAL AND TORIC LENSES
| Applicant | Alden Optical Labs., Inc., Alden NY, US |
| Decision | Substantially Equivalent, Apr 26, 2011 |
| Received | Sep 7, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102557
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2017 | Alden Optical NovaKone Daily Wear Soft contact; Catalog Number: AONKS54
Product Usage:
The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of ref Terminated |
LPL | None listed |
| Nov 3, 2017 | Alden Optical NovaKone Toric Daily Wear Soft contact; Catalog Number: AONKT54
Product Usage:
The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of r Terminated |
LPL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.