Company ยท US
Abbott Medical Optics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2017. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 19, 2017 | K170322 | Catalys Precision Laser System Abbott Medical Optics, Inc. | OOE |
| Apr 27, 2016 | K160236 | Dual Pump Pack Abbott Medical Optics, Inc. | HQC |
| Oct 19, 2015 | K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, Abbott Medical Optics, Inc. | HQC |
| Sep 2, 2015 | K151783 | COMPACT INTUITIV Multiple-Use Pack Abbott Medical Optics, Inc. | HQC |
| May 6, 2015 | K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series Abbott Medical Optics, Inc. | MSS |
| Feb 27, 2014 | K133115 | COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK Abbott Medical Optics, Inc. | HQC |
| Oct 15, 2012 | K121721 | LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE) Abbott Medical Optics, Inc. | HQC |
| Mar 8, 2012 | K113151 | IFS LASER SYSTEM Abbott Medical Optics, Inc. | GEX |
| Dec 21, 2011 | K111446 | SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM Abbott Medical Optics, Inc. | HQC |
| Nov 7, 2011 | K111882 | LAMINAR FLOW PHACO TIPS Abbott Medical Optics, Inc. | HQC |
| Sep 27, 2011 | K111697 | AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM Abbott Medical Optics, Inc. | HQC |
| Jun 1, 2011 | K103023 | UNIT, PHACOFRAGMENTATION Abbott Medical Optics, Inc. | HQC |
| Sep 15, 2010 | K093254 | AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION Abbott Medical Optics, Inc. | LPN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2015 | Abbott Medical Optics, Inc. OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Catalys-I (Outside US).
Product Usage:
Indicated for use in patients undergoing cataract surgery for removal of crystallin Terminated |
OOE | K141079 |
| Oct 22, 2013 | Abbott Medical Optics, Inc. STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product is manufactured and distributed by AMO Manufacturing USA, LLC
Milpitas, CA
The STAR Excimer Laser Systems are indicated Terminated |
LZS | None listed |
| Oct 22, 2013 | Abbott Medical Optics, Inc. STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA
The STAR Excimer Terminated |
LZS | None listed |
| Oct 22, 2013 | Abbott Medical Optics, Inc. STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA
The STAR Excimer Laser Systems are Terminated |
LZS | None listed |
| Oct 22, 2013 | Abbott Medical Optics, Inc. STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is manufactured and distributed by AMO Manufacturing USA, LLC,
Milpitas, CA
The STAR Excimer Laser Systems are indicated Terminated |
LZS | None listed |
| Jul 9, 2013 | Abbott Medical Optics, Inc. Sovereign Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery. Terminated |
HQC | K111446 |
| Jun 13, 2013 | Abbott Medical Optics, Inc. STAR S4 IR Excimer System (STAR S4 IR)
Mfg by AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in Terminated |
LZS | None listed |
| Jun 13, 2013 | Abbott Medical Optics, Inc. STAR S4 with Variable Spot Scanning Excimer System (STAR S4)
Mfg by AMO Manufacturing USA, LLC
510 Cottonwood Drive
Milpitas, CA 95035
The STAR Excimer Laser System, a class Ill device, is indicate Terminated |
LZS | None listed |
| Jun 13, 2013 | Abbott Medical Optics, Inc. STAR S3 ActiveTrack Excimer System (STAR S3)
Mfg by AMO Manufacturing USA, LLC
510 cottonwood Drive
Milpitas, CA 95035
The STAR Excimer Laser System, a class Ill device, is indicated for laser assi Terminated |
LZS | None listed |