Medical Device Manufacturer · US , Mchenry , IL

Staar Surgical Co.

22 submissions · 22 cleared · Since 1983
22
Total
22
Cleared
0
Denied

Staar Surgical Co. — FDA 510(k) Submissions

Staar Surgical Co. has submitted 22 FDA 510(k) premarket notifications since 1983, of which 22 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Unit, Phacofragmentation, Lens, Guide, Intraocular, Folders And Injectors, Intraocular Lens (iol), Culture Media, Non-propagating Transport, Instrument, Vitreous Aspiration And Cutting, Ac-powered . Use the specialty filter in the sidebar to narrow results.

22 devices
1–22 of 22
EPIPHANY INJECTION SYSTEM
K090161 · MSS Folders And Injectors,... · Ophthalmic
Jun 2009 138d
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
K073586 · MSS Folders And Injectors,... · Ophthalmic
Mar 2008 84d
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
K073591 · MSS Folders And Injectors,... · Ophthalmic
Mar 2008 84d
RE-USEABLE MICROSTAAR INJECTOR, MSI-S
K032412 · KYB Lens, Guide, Intraocular · Ophthalmic
Jun 2004 310d
SURGE-FREE ASPIRATION ADAPTER
K020734 · HQC Unit, Phacofragmentation · Ophthalmic
May 2002 71d
DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
K983129 · KYB Lens, Guide, Intraocular · Ophthalmic
Dec 1998 87d
FOAM TIP INJECTOR
K980696 · MSS Folders And Injectors,... · Ophthalmic
Sep 1998 200d
MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)
K954600 · KYB Lens, Guide, Intraocular · Ophthalmic
Dec 1995 87d
SOFTRANS INJECTOR
K913626 · HQL Intraocular Lens · Ophthalmic
Dec 1991 125d
STAAR PHACO XL SMALL INCISION SYSTEM
K884241 · HQC Unit, Phacofragmentation · Ophthalmic
Feb 1989 129d
MOLTENO VALVE SETON
K875099 · KYF Implant, Eye Valve · Ophthalmic
Mar 1988 111d
FAULKNER FORCEPS
K864071 · HNR Forceps, Ophthalmic · Ophthalmic
Nov 1986 24d
SOFT LENS FOLDER
K861990 · KYB Lens, Guide, Intraocular · Ophthalmic
Jun 1986 25d
ELASTIC LENS INJECTOR TM
K861085 · KYB Lens, Guide, Intraocular · Ophthalmic
May 1986 68d
BACSTOP FILTER IRRIGATION SUPPLY KIT
K860544 · KYG Device, Irrigation,... · Ophthalmic
Apr 1986 50d
MAZZOCCO/FRENCHIK FOLDER
K860148 · KYB Lens, Guide, Intraocular · Ophthalmic
Mar 1986 65d
STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT
K851936 · HQE Instrument, Vitreous... · Ophthalmic
Aug 1985 106d
PHACO-BAC STOP FILTER KIT
K852208 · HQC Unit, Phacofragmentation · Ophthalmic
Aug 1985 91d
I/A BAC STOP KIT
K850899 · HQC Unit, Phacofragmentation · Ophthalmic
Mar 1985 25d
PHACO-BAC STOP KIT
K850900 · HQC Unit, Phacofragmentation · Ophthalmic
Mar 1985 25d
ULTRAKIT
K831172 · HQC Unit, Phacofragmentation · Ophthalmic
Jun 1983 58d
I/A KIT
K831159 · JSM Culture Media,... · Microbiology
Apr 1983 17d
Filters