510(k) K002099 ยท LPL Lenses, Soft Contact, Daily Wear
S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY-
| Applicant | Bescon Co., Ltd., Grand Junction CO, US |
| Decision | Substantially Equivalent, Jul 9, 2001 |
| Received | Jul 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002099
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Eyezone Neulook Fancy FX is packaged in a small glass bottle with a orange, white, and yellow affixed label with black printing that reads,
NeuLook COLOR CONTACT LENSES Distributed by EYEZONE Contents : One Terminated |
LPL | None listed |
| Jan 11, 2012 | Eyezone Neulook Deluxe is packaged in a pink soft plastic box with white, black, and rainbow printing that reads,
NeuLook COLOR CONTACT LENSES Give yourself a whole new look***LENS CASE INCLUDED HOT RED PWR. Terminated |
LPL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.