Abbott Medical Optics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Catalys Precision Laser System, Dual Pump Pack, AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Abbott Medical Optics, Inc. Ophthalmic ✕
12 devices
Cleared
May 19, 2017
Catalys Precision Laser System
Ophthalmic
107d
Cleared
Apr 27, 2016
Dual Pump Pack
Ophthalmic
86d
Cleared
Oct 19, 2015
AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature...
Ophthalmic
124d
Cleared
Sep 02, 2015
COMPACT INTUITIV Multiple-Use Pack
Ophthalmic
63d
Cleared
May 06, 2015
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
Ophthalmic
156d
Cleared
Feb 27, 2014
COMPACT INTUITIV
Ophthalmic
150d
Cleared
Oct 15, 2012
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
Ophthalmic
125d
Cleared
Dec 21, 2011
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
Ophthalmic
211d
Cleared
Nov 07, 2011
LAMINAR FLOW PHACO TIPS
Ophthalmic
129d
Cleared
Sep 27, 2011
AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
Ophthalmic
102d
Cleared
Jun 01, 2011
UNIT, PHACOFRAGMENTATION
Ophthalmic
232d
Cleared
Sep 15, 2010
AMO BRAND MULTI-PURPOSE DISINFECTING SOLUTION
Ophthalmic
334d