Company ยท US
Allergan Medical Optics
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 1995. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 1995 | K951462 | AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM Allergan Medical Optics | HQC |
| Jul 6, 1994 | K941603 | AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE Allergan Medical Optics | KYB |
| Apr 7, 1994 | K930320 | AMO PHACOFLEX INSERTER, FOLDABLE IOL INSERT INSTR Allergan Medical Optics | KYB |
| Jan 7, 1993 | K925254 | AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 Allergan Medical Optics | HQC |
| Dec 23, 1992 | K924235 | AMO ELITE Allergan Medical Optics | HQC |
| Jul 26, 1991 | K911998 | MULTITOME MODEL 1000, VITRECTOMY DRIVING SYSTEM Allergan Medical Optics | HQE |
| Jun 16, 1989 | K893199 | PHACO-INJECTOR(TM) INTRAOCULAR LENS IMPLANT INSTR Allergan Medical Optics | HNR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Allergan Medical Optics Inc Surgical Tubing Pack, Model: AMO Prestige Pack, Product Code OPO40 Terminated |
HQC | K924235 |
| Jul 22, 2003 | Allergan Medical Optics Inc AMO PhacoFlex II Model SI40NB, Intraocular Lenses Terminated |
None listed |