510(k) K973967 ยท LPL Lenses, Soft Contact, Daily Wear
AL-47 (POLYMACON) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENS (CLEAR & TINTED, LATHE-CUT FROM LENS BLANK)
| Applicant | Alden Optical Labs., Inc., Grand Junction CO, US |
| Decision | Substantially Equivalent, Dec 8, 1997 |
| Received | Oct 17, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973967
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2017 | Alden Optical Alden Classic 38 Sphere Daily Wear Soft contact; Catalog Number: AOCLS38
Product Usage:
The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphaki Terminated |
LPL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.