510(k) K981252 ยท LPL Lenses, Soft Contact, Daily Wear
OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)
| Applicant | Alden Optical Labs., Inc., Grand Junction CO, US |
| Decision | Substantially Equivalent, Jun 23, 1998 |
| Received | Apr 6, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981252
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2017 | Alden Optical Alden HP49 Sphere Daily Wear Soft contact; Catalog Number: AOHPS49
Product Usage:
The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic pe Terminated |
LPL | None listed |
| Nov 3, 2017 | Alden Optical Alden HP49 Toric Daily Wear Soft contact; Catalog Number: AOHPT49
Product Usage:
The ALDEN TORIC LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic person Terminated |
LPL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.