510(k) K091327 ยท LPL Lenses, Soft Contact, Daily Wear
ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES
| Applicant | Alden Optical Labs., Inc., Alden NY, US |
| Decision | Substantially Equivalent, Jun 25, 2010 |
| Received | May 5, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091327
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2017 | Alden Optical Alden HP54 Sphere Daily Wear Soft contact; Catalog Number: AOHPS54
Product Usage:
The ALDEN SPHERE LENS for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic pers Terminated |
LPL | None listed |
| Nov 3, 2017 | Alden Optical Alden HP54 Toric Daily Wear Soft contact; Catalog Number: AOHPT54
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.