Medical Device Manufacturer · US , Mchenry , IL

Staar Surgical Co. - FDA 510(k) Cleared Devices

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

FDA 510(k) Regulatory Record - Staar Surgical Co. Ophthalmic

21 devices
1-21 of 21
Cleared Jun 09, 2009
EPIPHANY INJECTION SYSTEM
K090161 · MSS
Ophthalmic · 138d
Cleared Mar 13, 2008
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
K073586 · MSS
Ophthalmic · 84d
Cleared Mar 13, 2008
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
K073591 · MSS
Ophthalmic · 84d
Cleared Jun 10, 2004
RE-USEABLE MICROSTAAR INJECTOR, MSI-S
K032412 · KYB
Ophthalmic · 310d
Cleared May 16, 2002
SURGE-FREE ASPIRATION ADAPTER
K020734 · HQC
Ophthalmic · 71d
Cleared Dec 04, 1998
DISPOSABLE MICROSTAAR INJECTOR (MODEL MSI-P1)
K983129 · KYB
Ophthalmic · 87d
Cleared Sep 11, 1998
FOAM TIP INJECTOR
K980696 · MSS
Ophthalmic · 200d
Cleared Dec 21, 1995
MICROSTAAR INJECTOR MODELS MSI-TD & MSI-PD (MODIFICATION)
K954600 · KYB
Ophthalmic · 87d
Cleared Dec 18, 1991
SOFTRANS INJECTOR
K913626 · HQL
Ophthalmic · 125d
Cleared Feb 17, 1989
STAAR PHACO XL SMALL INCISION SYSTEM
K884241 · HQC
Ophthalmic · 129d
Cleared Mar 30, 1988
MOLTENO VALVE SETON
K875099 · KYF
Ophthalmic · 111d
Cleared Nov 13, 1986
FAULKNER FORCEPS
K864071 · HNR
Ophthalmic · 24d
Cleared Jun 17, 1986
SOFT LENS FOLDER
K861990 · KYB
Ophthalmic · 25d
Cleared May 28, 1986
ELASTIC LENS INJECTOR TM
K861085 · KYB
Ophthalmic · 68d
Cleared Apr 04, 1986
BACSTOP FILTER IRRIGATION SUPPLY KIT
K860544 · KYG
Ophthalmic · 50d
Cleared Mar 21, 1986
MAZZOCCO/FRENCHIK FOLDER
K860148 · KYB
Ophthalmic · 65d
Cleared Aug 20, 1985
STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT
K851936 · HQE
Ophthalmic · 106d
Cleared Aug 20, 1985
PHACO-BAC STOP FILTER KIT
K852208 · HQC
Ophthalmic · 91d
Cleared Mar 29, 1985
I/A BAC STOP KIT
K850899 · HQC
Ophthalmic · 25d
Cleared Mar 29, 1985
PHACO-BAC STOP KIT
K850900 · HQC
Ophthalmic · 25d
Cleared Jun 08, 1983
ULTRAKIT
K831172 · HQC
Ophthalmic · 58d
Filters