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Review Panel
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Review Panel
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Review Panel
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Review Panel
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Ophthalmic
Review Panel
Diagnostic Devices
CFR Sub-Part
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
HLD
Engine, Trephine, Accessories, Gas-Powered
1
Product Code
HKP
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
2
Product Code
FCT
Headlight, Fiberoptic Focusing
2
Product Code
FSR
Light, Headband, Surgical
2
Product Code
FTZ
Locator, Magnetic
1
Product Code
HMQ
Marker, Sclera
1
Product Code
HMR
Marker, Ocular
1
Product Code
HMS
Drum, Eye Knife Test
1
Product Code
HMX
Cannula, Ophthalmic
1
Product Code
HMY
Keratome, Battery-Powered
1
Product Code
HMZ
Trabeculotome
1
Product Code
HNA
Spud, Ophthalmic
1
Product Code
HNB
Spoon, Ophthalmic
1
Product Code
HNC
Specula, Ophthalmic
1
Product Code
HND
Spatula, Ophthalmic
1
Product Code
HNE
Snare, Enucleating
1
Product Code
HNF
Scissors, Ophthalmic
1
Product Code
HNG
Rongeur, Lachrymal Sac
1
Product Code
HNH
Ring, Ophthalmic (Flieringa)
1
Product Code
HNI
Retractor, Ophthalmic
1
Product Code
HNJ
Punch, Corneo-Scleral
1
Product Code
HNK
Probe, Trabeculotomy
1
Product Code
HNL
Probe, Lachrymal
1
Product Code
HNM
Needle, Ophthalmic Suturing
1
Product Code
HNN
Knife, Ophthalmic
1
Product Code
HNO
Keratome, Ac-Powered
1
Product Code
HNP
Introducer, Sphere
1
Product Code
HNQ
Hook, Ophthalmic
1
Product Code
HNR
Forceps, Ophthalmic
1
Product Code
HNS
Expressor
1
Product Code
HNT
Erisophake
1
Product Code
HNW
Dilator, Lachrymal
1
Product Code
HNX
Depressor, Orbital
1
Product Code
HNY
Cystotome
1
Product Code
HNZ
Curette, Ophthalmic
1
Product Code
HOA
Compressor, Orbital
1
Product Code
HOB
Clamp, Muscle, Ophthalmic
1
Product Code
HOC
Clip, Iris Retractor
1
Product Code
HOD
Clamp, Eyelid, Ophthalmic
1
Product Code
HOE
Caliper, Ophthalmic
1
Product Code
HOF
Burr, Corneal, Manual
1
Product Code
HOG
Burr, Corneal, Battery-Powered
1
Product Code
HOH
Spectacle, Operating (Loupe), Ophthalmic
1
Product Code
HOY
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
1
Product Code
HOZ
Sponge, Ophthalmic
2
Product Code
HPM
Locator, Metal, Electronic
2
Product Code
HPN
Magnet, Permanent
1
Product Code
HPO
Magnet, Ac-Powered
2
Product Code
HPP
Headlamp, Operating, Battery-Operated
1
Product Code
HPQ
Headlamp, Operating, Ac-Powered
2
Product Code
HPS
Unit, Cryophthalmic
2
Product Code
HPY
Unit, Electrolysis, Battery-Powered, Ophthalmic
1
Product Code
HQA
Unit, Cryotherapy, Ophthalmic
2
Product Code
HQB
Photocoagulator And Accessories
2
Product Code
HQC
Unit, Phacofragmentation
2
Product Code
K
21
2241
QUATERA 700
2
Cleared 510(K)
K
20
3060
VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control
2
Cleared 510(K)
K
20
0207
xPORT S Lens Fragmentation System
2
Cleared 510(K)
K
20
0584
xPORT 304 (miCOR) System Lens Fragmentation System
2
Cleared 510(K)
K
19
3376
Visalis V500, Visalis S500
2
Cleared 510(K)
K
19
2418
Phacoemulsification Needle (Tip) and Irrigation Sleeve
2
Cleared 510(K)
K
19
1650
LEGION System
2
Cleared 510(K)
K
19
0875
EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
2
Cleared 510(K)
K
19
1933
COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
2
Cleared 510(K)
K
19
1024
xPORT Lens Fragmentation System
2
Cleared 510(K)
K
17
0052
Stellaris Elite vision enhancement system
2
Cleared 510(K)
K
16
1794
CENTURION Vision System (Active SentryTM)
2
Cleared 510(K)
K
16
2342
Stellaris Elite Vision Enhancement System
2
Cleared 510(K)
K
16
0236
Dual Pump Pack
2
Cleared 510(K)
K
15
1636
AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
2
Cleared 510(K)
K
15
1783
COMPACT INTUITIV Multiple-Use Pack
2
Cleared 510(K)
K
14
2877
EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)
2
Cleared 510(K)
K
13
3562
CATARHEX 3
2
Cleared 510(K)
K
13
3486
STELLARIS PC VISION ENHANCEMENT SYSTEM
2
Cleared 510(K)
K
13
3115
COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK
2
Cleared 510(K)
K
13
3242
STELLARIS VISION ENHANCEMENT SYSTEM
2
Cleared 510(K)
K
12
1555
CENTURION VISION SYSTEM
2
Cleared 510(K)
K
12
2829
LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS
2
Cleared 510(K)
K
12
1721
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
2
Cleared 510(K)
K
12
0732
LENSSX LASER SYSTEM
2
Cleared 510(K)
K
12
0912
INFINITI(R) VISION SYSTEM
2
Cleared 510(K)
K
11
1446
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
2
Cleared 510(K)
K
11
2425
INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
2
Cleared 510(K)
K
11
1882
LAMINAR FLOW PHACO TIPS
2
Cleared 510(K)
K
11
1697
AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
2
Cleared 510(K)
K
10
3023
UNIT, PHACOFRAGMENTATION
2
Cleared 510(K)
K
10
1285
CONSTELLATION VISION SYSTEM
2
Cleared 510(K)
K
10
1325
STELLARIS PC VISION ENHANCEMENT SYSTEM
2
Cleared 510(K)
K
09
3210
AQUALASE CAPSULE WASH TIP
2
Cleared 510(K)
K
09
1915
FLUID ISOLATION DEVICE
2
Cleared 510(K)
K
09
1777
ALCON ULTRACHOPPER
2
Cleared 510(K)
K
08
2845
INFINITI VISION SYSTEM WITH OZIL IP
2
Cleared 510(K)
K
08
2473
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
2
Cleared 510(K)
K
08
1877
ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
2
Cleared 510(K)
K
08
0803
VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551
2
Cleared 510(K)
K
08
2132
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
2
Cleared 510(K)
K
06
3583
ALCON VISION SYSTEM
2
Cleared 510(K)
K
07
3023
STERILS SINGLE-USE I/A HANDPIECES
2
Cleared 510(K)
K
06
3331
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
2
Cleared 510(K)
K
06
0366
THE AMO OPHTHALMIC SURGICAL SYSTEM
2
Cleared 510(K)
K
05
1186
MICROPULSE PHACOEMULSIFICATION SYSTEM
2
Cleared 510(K)
K
05
0648
SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK
2
Cleared 510(K)
K
04
1998
PHACO CHOP NEEDLES
2
Cleared 510(K)
K
03
3653
VENTURI PHACO PACK
2
Cleared 510(K)
K
03
0957
PERFECT CAPSULE
2
Cleared 510(K)
K
03
1404
DIGNITY OPHTHALMIC SURGICAL SYSTEM
2
Cleared 510(K)
K
02
2833
BENJAMIN ENVOY PHACO HANDPIECE
2
Cleared 510(K)
K
02
0527
HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
2
Cleared 510(K)
K
02
1566
INFINITI
2
Cleared 510(K)
K
02
0734
SURGE-FREE ASPIRATION ADAPTER
2
Cleared 510(K)
K
00
3638
MOJAVE CATARACT EXTRACTION SYSTEM
2
Cleared 510(K)
K
00
3512
LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
2
Cleared 510(K)
K
00
2932
PHACOGARD
2
Cleared 510(K)
K
00
2031
PHACOFRAGMENTATION SYSTEM MEGATRON
2
Cleared 510(K)
K
00
2986
A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
2
Cleared 510(K)
K
00
2812
IRIS RETRACTING PHACOEMULSIFICATION SLEEVE
2
Cleared 510(K)
K
99
1852
OCUSYSTEM ART ADVANTAGE, MODEL 995
2
Cleared 510(K)
K
98
4143
FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
2
Cleared 510(K)
K
98
1989
THE WAVE DIGITAL PHACO SYSTEM
2
Cleared 510(K)
K
98
1103
TURBOSONICS LIMITED REUSE ULTRASONIC TIP
2
Cleared 510(K)
K
98
1109
QUITETIP
2
Cleared 510(K)
K
98
0480
SYNTEC VITMAN
2
Cleared 510(K)
K
98
0085
PHACO COMMANDER
2
Cleared 510(K)
K
97
4469
MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL
2
Cleared 510(K)
K
97
4719
PHACOPAK
2
Cleared 510(K)
K
97
3749
FRAG COMMANDER
2
Cleared 510(K)
K
97
2063
WHITTINGHAM ULTRACLEAN PHACO HANDPIECE
2
Cleared 510(K)
K
97
2252
VISTA UNIVERSAL HANDPIECE
2
Cleared 510(K)
K
97
2253
P3 UNIVERSAL PHACO HANDPIECE
2
Cleared 510(K)
K
97
1795
AUTOMATED CHAMBER MAINTENANCE MODULE
2
Cleared 510(K)
K
97
1750
WELCH ALLYN PHACO ILLUMINATOR
2
Cleared 510(K)
K
97
1439
STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
2
Cleared 510(K)
K
97
1186
AMO DIPLOMAX/OPSYS CONSOLE
2
Cleared 510(K)
K
97
1064
BAYERS BIMANUAL I/A HANDPIECES
2
Cleared 510(K)
K
96
5127
DGH MODEL 9000
2
Cleared 510(K)
K
96
4018
PHACOILLUMINATOR - FIBEROPTIC SLEEVE
2
Cleared 510(K)
K
96
0287
HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM
2
Cleared 510(K)
K
96
0811
PHACOSCOPE
2
Cleared 510(K)
K
96
0024
STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH
2
Cleared 510(K)
K
96
2402
AMO PRESTIGE DAY PACK (ALLERGAN, INC.)
2
Cleared 510(K)
K
96
0003
STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION
2
Cleared 510(K)
K
96
2131
STORZ D4600 AIR EXCHANGE LINE PACK
2
Cleared 510(K)
K
96
1874
STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK
2
Cleared 510(K)
K
96
1831
STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK
2
Cleared 510(K)
K
96
1820
STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK
2
Cleared 510(K)
K
96
2431
CTM DISPOSABLE PAK
2
Cleared 510(K)
K
96
2430
CTM REUSABLE PAK
2
Cleared 510(K)
K
96
1658
MEGATRON OPHTHALMIC SURGICAL SYSTEM
2
Cleared 510(K)
K
96
1243
OCUSYSTEM ART ADVANTAGE
2
Cleared 510(K)
K
96
1310
STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)
2
Cleared 510(K)
K
96
0414
SYNERGIST POWER PACK
2
Cleared 510(K)
K
95
5901
STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX
2
Cleared 510(K)
K
95
5789
ALCON SERIES 20000 LEGACY MACKOOL SYSTEM
2
Cleared 510(K)
K
95
5245
MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM
2
Cleared 510(K)
K
95
4746
PHACO TIP
2
Cleared 510(K)
K
95
3538
RM001 REUSABLE
2
Cleared 510(K)
K
95
3539
DM001 DISPOSABLE PACK
2
Cleared 510(K)
K
95
4340
STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE
2
Cleared 510(K)
K
95
4239
U.S. IOL PHACO HANDPIECE
2
Cleared 510(K)
K
95
4238
SURGIN GENISIS HANDPIECE
2
Cleared 510(K)
K
95
4237
CIRCUIT TREE PHACO HANDPIECE
2
Cleared 510(K)
K
95
4241
SURGIN GENISIS PHACOEMULSIFIER
2
Cleared 510(K)
K
95
4240
EVOLUTION PHACOMULSIFIER
2
Cleared 510(K)
K
95
4242
CIRCUIT TREE PHACOEMULSIFIER
2
Cleared 510(K)
K
95
3959
PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES
2
Cleared 510(K)
K
95
1463
STORZ I/A HANDPIECES
2
Cleared 510(K)
K
95
3359
TRI-STAR UNIVERSAL I/A PHACO PAK
2
Cleared 510(K)
K
95
3447
PRECISIONIST THIRTY THOUSAND
2
Cleared 510(K)
K
94
4993
IOLAB.SITE CD PHACOEMULSIFICATION MODULE
2
Cleared 510(K)
K
94
4995
IOLAB/SITE PERISTALTIC MODULE
2
Cleared 510(K)
K
95
0881
PHACO TIP
2
Cleared 510(K)
K
95
2468
HI-LINE MEDICAL PHACOEMULSIFIER TIP
2
Cleared 510(K)
K
95
2331
AOI LC-40 PHACOEMULSIFIER
2
Cleared 510(K)
K
95
2213
ALCON SERIES 20000 LEGACY PHACOEMULSIFIER
2
Cleared 510(K)
K
95
3078
STORZ DP4101 BASIC I/A PACK
2
Cleared 510(K)
K
95
1824
STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)
2
Cleared 510(K)
K
95
0218
OMS SLIMLINE PHACO HANDPIECE
2
Cleared 510(K)
K
94
6054
DIPLOMAX
2
Cleared 510(K)
K
95
1462
AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM
2
Cleared 510(K)
K
95
2259
STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES
2
Cleared 510(K)
K
95
0114
STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM
2
Cleared 510(K)
K
95
0880
AOI UNIVERSAL ULTRASONIC HANDPIECE
2
Cleared 510(K)
K
95
0798
POSTERIOR CAPSULE SHIELD
2
Cleared 510(K)
K
95
0800
PRO-PAK FOR OMS DIPLOMATE
2
Cleared 510(K)
K
95
0600
VACUUM SURGE SUPRESSER
2
Cleared 510(K)
K
94
6227
STORZ PREMIERE(R) MICROSURGICAL SYSTEM
2
Cleared 510(K)
K
94
4994
IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE
2
Cleared 510(K)
K
94
6176
STORZ PHACOEMULSIFICATION NEEDLES
2
Cleared 510(K)
K
94
5583
OCUSYSTEM(ART)
2
Cleared 510(K)
K
94
2945
CASSETTE SYSTEM FOR STORZ
2
Cleared 510(K)
K
93
5926
STORZ PHACO AND FRAG HANDPIECES
2
Cleared 510(K)
K
94
3672
PHACO NEEDLES AND TIPS
2
Cleared 510(K)
K
94
3379
PHACO TIPS FOR PHACO FRAGMENTATION MACHINES
2
Cleared 510(K)
K
94
0083
STANDARD PHACO TIP 15, 30, 45, 60
2
Cleared 510(K)
K
94
0088
MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE
2
Cleared 510(K)
K
94
3102
HIGH PERFORMANCE TIPS
2
Cleared 510(K)
K
94
2515
PHACO KIT
2
Cleared 510(K)
K
94
2517
10-K CASSETTE
2
Cleared 510(K)
K
94
2518
CASSETTE SYSTEM FOR SITE
2
Cleared 510(K)
K
94
2516
10-0 CASSETTE
2
Cleared 510(K)
K
94
0084
MODEL 2000 OPHTHALMIC SURGICAL SYSTEM
2
Cleared 510(K)
K
92
3630
PHACO NEEDLES 1000-R & 1000-O NEEDLES
2
Cleared 510(K)
K
93
5223
OPHTHALMIC SURGICAL SYSTEM
2
Cleared 510(K)
K
93
1358
AORP4000 REUSABLE PAK
2
Cleared 510(K)
K
93
1354
P4000 PHACOEMULSIFIER
2
Cleared 510(K)
K
92
5828
MODIFIED SITE TXR SYSTEMS
2
Cleared 510(K)
K
93
3627
PHACOFRAGMENTOR TIP
2
Cleared 510(K)
K
93
1357
AOD4000 DISPOSABLE PAK
2
Cleared 510(K)
K
93
3503
PRO-PHACO HANDPIECE
2
Cleared 510(K)
K
92
6381
OCUSYSTEM IIE
2
Cleared 510(K)
K
93
1866
SITE'S CD II PHACOEMULSIFICATION HANDPIECE
2
Cleared 510(K)
K
92
6512
STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE
2
Cleared 510(K)
K
92
5631
PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE
2
Cleared 510(K)
K
92
4260
NIDEK CV-12000
2
Cleared 510(K)
K
92
3725
OPHTHALMIC PHARCO NEEDLE
2
Cleared 510(K)
K
92
5254
AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38
2
Cleared 510(K)
K
92
4235
AMO ELITE
2
Cleared 510(K)
K
92
4033
ALTEX MODEL UST-3000E
2
Cleared 510(K)
K
92
2595
MODIFIED SITE MACROBORE PHACO NEEDLE
2
Cleared 510(K)
K
92
1607
IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE
2
Cleared 510(K)
K
91
2904
MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM
2
Cleared 510(K)
K
92
1135
IOLAB POWER I.V. POLE
2
Cleared 510(K)
K
91
5457
PHACO 20/20 SYSTEM I
2
Cleared 510(K)
K
91
5456
PHACO 3000 LINEAR
2
Cleared 510(K)
K
91
5118
PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE
2
Cleared 510(K)
K
91
4229
PHACO TIP
2
Cleared 510(K)
K
91
2902
PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE
2
Cleared 510(K)
K
91
4172
KPE 230 AM
2
Cleared 510(K)
K
91
3530
LOOK VISCODISSECTOR
2
Cleared 510(K)
K
91
2739
SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
2
Cleared 510(K)
K
91
1808
GEMINI OPHTHALMIC SURGERY SYSTEM
2
Cleared 510(K)
K
90
4612
I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)
2
Cleared 510(K)
K
90
4183
SITE PHACOEMULSIFICATION HANDPIECE
2
Cleared 510(K)
K
90
4151
SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE
2
Cleared 510(K)
K
90
2876
PHACOTRON SYSTEMS PLUS III PHACOEMULSIFIER ASPI.
2
Cleared 510(K)
K
90
2798
AUTOMATED HYDROSONICS(TM)
2
Cleared 510(K)
K
90
0493
THE PRECISIONIST
2
Cleared 510(K)
K
90
2150
PIEZO HANDPIECE
2
Cleared 510(K)
K
90
1686
NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000
2
Cleared 510(K)
K
89
4512
PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS
2
Cleared 510(K)
K
89
4511
MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT
2
Cleared 510(K)
K
89
2852
SITE PHACO PLUS INFUSION SLEEVE
2
Cleared 510(K)
K
89
1161
VITRECTOMY PACK #J120
2
Cleared 510(K)
K
89
0825
JUMPER PACK #203
2
Cleared 510(K)
K
89
2911
SITE PERISTALTIC CASSETTE
2
Cleared 510(K)
K
89
0635
CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.
2
Cleared 510(K)
K
89
0080
PHACOEMULSIFIER MODEL 100
2
Cleared 510(K)
K
88
4241
STAAR PHACO XL SMALL INCISION SYSTEM
2
Cleared 510(K)
K
88
3097
GV3000 PHACOEMULSIFIER/FRAGMENTER
2
Cleared 510(K)
K
88
3199
MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM
2
Cleared 510(K)
K
88
3099
SITE MACROBORE PHACO NEEDLE
2
Cleared 510(K)
K
88
2103
SITE ULTRASONIC I/A PHACO NEEDLE
2
Cleared 510(K)
K
88
1635
NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM
2
Cleared 510(K)
K
88
0062
C-MATE #CMU 1001
2
Cleared 510(K)
K
87
4334
SOLOS SINGLE USE TITANIUM TIP
2
Cleared 510(K)
K
87
2611
SOLOS EYESITE CAP SLEEVE
2
Cleared 510(K)
K
87
1473
PART #860065 IA PAK & PART #860060 IA PAK
2
Cleared 510(K)
K
87
2362
FRIGITRONICS ACC-1000 CAPSULE CUTTER
2
Cleared 510(K)
K
87
1854
IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS
2
Cleared 510(K)
K
87
1485
SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE
2
Cleared 510(K)
K
87
1649
CLASSIC 70 LENS
2
Cleared 510(K)
K
87
0671
PHACOTRON DAY PAK
2
Cleared 510(K)
K
87
0806
NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100
2
Cleared 510(K)
K
86
4726
I/A/KPE TIP
2
Cleared 510(K)
K
86
4301
SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD)
2
Cleared 510(K)
K
86
4056
GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT
2
Cleared 510(K)
K
86
3444
GRIESHABER GLOBAL CONTROL TUBING SET
2
Cleared 510(K)
K
86
3729
OPHTHALMIC FITLER MICRO CAPSULE
2
Cleared 510(K)
K
86
3209
US PLUS-PAK(R) SURGICAL SYSTEM
2
Cleared 510(K)
K
86
2777
MODEL A-8000 ULTRASONIC HANDPIECE CORD
2
Cleared 510(K)
K
86
2021
PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM
2
Cleared 510(K)
K
86
2064
ENTRAVISION EP-500 I/A ECCO PACK
2
Cleared 510(K)
K
86
2063
ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE
2
Cleared 510(K)
K
86
0956
KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.
2
Cleared 510(K)
K
86
0957
DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.
2
Cleared 510(K)
K
86
1060
SITE PHACO DISPOSABLE CASSETTE
2
Cleared 510(K)
K
86
0989
SITE DISPOSABLE CASSETTE
2
Cleared 510(K)
K
86
0770
AM-100 I/A AMPAC
2
Cleared 510(K)
K
85
4375
COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR
2
Cleared 510(K)
K
85
4225
ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS
2
Cleared 510(K)
K
85
4116
PHACO PACKS, 1A PACKS & PACK COMPONENTS
2
Cleared 510(K)
K
84
4373
O.M.S. ULTRA-PHACO
2
Cleared 510(K)
K
85
3883
TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR
2
Cleared 510(K)
K
85
3189
CREAT BRAND I/A PACK CREAT BRAND PHACO PACK
2
Cleared 510(K)
K
85
3070
COOPER VISION SYSTEM VI U/S MODULE
2
Cleared 510(K)
K
85
2208
PHACO-BAC STOP FILTER KIT
2
Cleared 510(K)
K
85
1674
PHAKOSYSTEMS MODEL CES 4100
2
Cleared 510(K)
K
85
1211
PHACO PAK I
2
Cleared 510(K)
K
85
1212
UNITED SONICS PACO SYSTEM MODEL 3000
2
Cleared 510(K)
K
85
1209
CILCO/UNITED SONICS PHACE PF-9000
2
Cleared 510(K)
K
85
1210
UNITED SONICS PHACO MODULE, DF-35
2
Cleared 510(K)
K
85
1298
MID LABS MVSXI
2
Cleared 510(K)
K
84
3276
IOCARE CONVERTER KIT
2
Cleared 510(K)
K
85
0532
ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK
2
Cleared 510(K)
K
85
0275
KCP PAK #2 CONVENIENCE PACK MODIFICATION
2
Cleared 510(K)
K
85
0148
KCP PAK CONVENIENCE PACK
2
Cleared 510(K)
K
85
0149
KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA
2
Cleared 510(K)
K
85
1009
INFUSION SLEEVE - OPHTHALMIC
2
Cleared 510(K)
K
85
0578
PHACOEMULSIFICATION TIP
2
Cleared 510(K)
K
85
0899
I/A BAC STOP KIT
2
Cleared 510(K)
K
85
0900
PHACO-BAC STOP KIT
2
Cleared 510(K)
K
84
3487
VISITEC OPHTHALMIC FLUID DISTRIB- SET
2
Cleared 510(K)
K
84
3319
CILCO I/A SURGICAL PACK
2
Cleared 510(K)
K
84
4666
SITE ULTRASONIC EMULSIFICATION MODULE OP
2
Cleared 510(K)
K
84
4150
MEDICAL OPTICS PHACOEMULSIFICATION KIT
2
Cleared 510(K)
K
84
2945
COOPERVISION SYSTEM VI
2
Cleared 510(K)
K
84
3386
MENDEZ U/S CYSTOTOME
2
Cleared 510(K)
K
84
3278
IOCARE ULTRASONIC TITANIUM TIPS
2
Cleared 510(K)
K
84
3277
IOCARE PHACOEMULSIFICATION PACK
2
Cleared 510(K)
K
84
3275
IOCARE IRRIGATION/ASPIRATION PACK
2
Cleared 510(K)
K
84
2979
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
2
Cleared 510(K)
K
84
0181
CATAREX/ULTRASONICS KIT
2
Cleared 510(K)
K
84
0063
CATAREX VITRECUTTER I/A DISPOS. CUT
2
Cleared 510(K)
K
84
2458
SITE SIMCOE STYLE I/A HANDPIECE
2
Cleared 510(K)
K
84
0495
MANUAL IRRIGATING/ASPIRATING UNIT
2
Cleared 510(K)
K
84
0695
PHACOEMULSIFICATION KITS
2
Cleared 510(K)
K
84
0965
SITE COAXIAL I/A HANDPIECE 30 TIP
2
Cleared 510(K)
K
83
4340
IOCARE IRRIGATION & ASPIRATION PACK
2
Cleared 510(K)
K
84
1072
IRRIGATION, ASPIRATION TUBING SETS
2
Cleared 510(K)
K
83
4453
PHACO FRAGMENTOR GT-1
2
Cleared 510(K)
K
83
4537
MICRO VIT FRAGMENTATION SYSTEM
2
Cleared 510(K)
K
83
4543
OCUCARE ULTRASOUND TIP & FREEDOM PACK
2
Cleared 510(K)
K
83
4261
PLASTIC OPTICAL LENS M-110
2
Cleared 510(K)
K
83
3465
DISPOSABLE FIBER OPTIC ILLUMINATOR
2
Cleared 510(K)
K
83
3962
KPE PLUS-PAK SURGICAL SYSTEM
2
Cleared 510(K)
K
83
3961
I/A PLUS PAK SURGICAL SYSTEM
2
Cleared 510(K)
K
83
3783
DISPOS. I/A & IRRIGATION HANDPIECES
2
Cleared 510(K)
K
83
3642
PHAKO SYSTEMS VIA 2000
2
Cleared 510(K)
K
83
3784
DISPOSABLE I/A HANDPIECE
2
Cleared 510(K)
K
83
3405
IRRIGATION ASPIRATION KIT
2
Cleared 510(K)
K
83
3800
BEECHER 20 GA. PROBE
2
Cleared 510(K)
K
83
3064
STORZ EXTRA
2
Cleared 510(K)
K
83
2529
M.S.D. ASPIRATOR
2
Cleared 510(K)
K
83
3697
EXTRA SENSORY PAK-DISPOS. ACCESS
2
Cleared 510(K)
K
83
3617
EXTRA PLUS TM
2
Cleared 510(K)
K
83
4161
UNIVERSAL PAC
2
Cleared 510(K)
K
83
4159
PHACOTRON PLUS
2
Cleared 510(K)
K
83
4158
EXTRA SENSORY PLUS
2
Cleared 510(K)
K
83
2980
VXTRA OCUTOME KIT
2
Cleared 510(K)
K
83
2997
EPA AUTOMATED INFUSION POLE
2
Cleared 510(K)
K
83
2413
SIAS IRRIGATION/ASPIRATION SYSTEM
2
Cleared 510(K)
K
83
2559
OCUCARE FREEDOM PACK
2
Cleared 510(K)
K
83
2423
ENVISION G21 I/A ENPAK
2
Cleared 510(K)
K
83
2424
ENVISION G31 P.E. PAK
2
Cleared 510(K)
K
83
1701
UNIVERSAL PACK
2
Cleared 510(K)
K
83
1836
EPSILON ULTRASONIC TIP
2
Cleared 510(K)
K
83
1172
ULTRAKIT
2
Cleared 510(K)
K
83
0812
ALPHAMEDIX I/A HAND-PIECE, 500-001
2
Cleared 510(K)
K
83
0902
OCUCARE PACK
2
Cleared 510(K)
K
82
3088
ASPITRON
2
Cleared 510(K)
K
83
0474
IV STAND
2
Cleared 510(K)
K
83
0385
IRRIGATION/ASPIRATION KIT
2
Cleared 510(K)
K
83
0379
PHAKO KIT
2
Cleared 510(K)
K
81
2126
ULTRASONIC TIPS
2
Cleared 510(K)
K
80
2381
LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.
2
Cleared 510(K)
K
78
2141
LEVIGATOR, KEELER PHOKO
2
Cleared 510(K)
K
77
1644
FRAGMATOME MODEL 820
2
Cleared 510(K)
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
2
Product Code
HQF
Laser, Ophthalmic
2
Product Code
HQO
Unit, Cautery, Thermal, Ac-Powered
2
Product Code
HQP
Unit, Cautery, Thermal, Battery-Powered
2
Product Code
HQQ
Apparatus, Cautery, Radiofrequency, Battery-Powered
2
Product Code
HQR
Apparatus, Cautery, Radiofrequency, Ac-Powered
2
Product Code
HQS
Burr, Corneal, Ac-Powered
1
Product Code
HRF
Engine, Trephine, Accessories, Battery-Powered
1
Product Code
HRG
Engine, Trephine, Accessories, Ac-Powered
1
Product Code
HRH
Trephine, Manual, Ophthalmic
1
Product Code
HRJ
Table, Instrument, Powered, Ophthalmic
1
Product Code
HRK
Table, Instrument, Manual, Ophthalmic
1
Product Code
HRN
Unit, Cryophthalmic, Ac-Powered
2
Product Code
HRO
Unit, Electrolysis, Ac-Powered, Ophthalmic
2
Product Code
HRP
Pen, Marking, Surgical
1
Product Code
KYB
Lens, Guide, Intraocular
1
Product Code
KYG
Device, Irrigation, Ocular Surgery
1
Product Code
LCC
Applicator, Ocular Pressure
2
Product Code
LPO
Gases Used Within Eye To Place Pressure On Detached Retina
3
Product Code
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
2
Product Code
LWL
Fluid, Intraocular
3
Product Code
LXP
Plug, Scleral
2
Product Code
LXS
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
2
Product Code
LZP
Aid, Surgical, Viscoelastic
3
Product Code
MLZ
Vitrectomy, Instrument Cutter
2
Product Code
MMC
Dilator, Expansive Iris (Accessory)
2
Product Code
MOE
Collagen Corneal Shield
1
Product Code
MSR
Tubing, Replacement, Phacofragmentation Unit
2
Product Code
MSS
Folders And Injectors, Intraocular Lens (Iol)
1
Product Code
MUS
Fluidic, Phacoemulsification/Phacofragmentation
2
Product Code
MXO
Laser, System, Phacolysis
2
Product Code
MXY
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
1
Product Code
MYD
Keratome, Water Jet
1
Product Code
NCE
Injector, Capsular Tension Ring
1
Product Code
NCR
Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
2
Product Code
NGY
Cannula, Trocar, Ophthalmic
1
Product Code
NKX
Needle, Phacoemulsification, Reprocessed
2
Product Code
NKY
Blade, Keratome, Reprocessed
1
Product Code
NLA
Knife, Ophthalmic, Reprocessed
1
Product Code
NVB
Intraocular, Pressure Measuring Device
3
Product Code
OHW
Burr, Corneal, Battery Powered, Rust Ring Removal
1
Product Code
OHX
Burr, Corneal, Ac-Powered, Rust Ring Removal
1
Product Code
OJK
Eye Tray
2
Product Code
OOE
Ophthalmic Femtosecond Laser
2
Product Code
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
1
Product Code
PUL
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
2
Product Code
PZG
Surgical Eye Tray
1
Product Code
QDV
Iol Tray
1
Product Code
QDW
Phaco Kit
2
Product Code
QDY
Vitrectomy Kit
2
Product Code
QGJ
Corneal Inlay Inserter Handle
1
Product Code
QQQ
Guide And Positioner, Ophthalmic Drug Delivery Device
1
Product Code
PYU
Sponge, Eyelid Cleaning, Powered
1
Product Code
Therapeutic Devices
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K833783
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DISPOS. I/A & IRRIGATION HANDPIECES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K833783
510(k) Type
Traditional
Applicant
COOPERVISION, INC.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
3/5/1984
Days to Decision
129 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Diagnostic Devices
General Hospital and Personal Use Therapeutic Devices
Miscellaneous
Prosthetic Devices
Surgical Devices
HLD
Engine, Trephine, Accessories, Gas-Powered
HKP
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
FCT
Headlight, Fiberoptic Focusing
FSR
Light, Headband, Surgical
FTZ
Locator, Magnetic
HMQ
Marker, Sclera
HMR
Marker, Ocular
HMS
Drum, Eye Knife Test
HMX
Cannula, Ophthalmic
HMY
Keratome, Battery-Powered
HMZ
Trabeculotome
HNA
Spud, Ophthalmic
HNB
Spoon, Ophthalmic
HNC
Specula, Ophthalmic
HND
Spatula, Ophthalmic
HNE
Snare, Enucleating
HNF
Scissors, Ophthalmic
HNG
Rongeur, Lachrymal Sac
HNH
Ring, Ophthalmic (Flieringa)
HNI
Retractor, Ophthalmic
HNJ
Punch, Corneo-Scleral
HNK
Probe, Trabeculotomy
HNL
Probe, Lachrymal
HNM
Needle, Ophthalmic Suturing
HNN
Knife, Ophthalmic
HNO
Keratome, Ac-Powered
HNP
Introducer, Sphere
HNQ
Hook, Ophthalmic
HNR
Forceps, Ophthalmic
HNS
Expressor
HNT
Erisophake
HNW
Dilator, Lachrymal
HNX
Depressor, Orbital
HNY
Cystotome
HNZ
Curette, Ophthalmic
HOA
Compressor, Orbital
HOB
Clamp, Muscle, Ophthalmic
HOC
Clip, Iris Retractor
HOD
Clamp, Eyelid, Ophthalmic
HOE
Caliper, Ophthalmic
HOF
Burr, Corneal, Manual
HOG
Burr, Corneal, Battery-Powered
HOH
Spectacle, Operating (Loupe), Ophthalmic
HOY
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
HOZ
Sponge, Ophthalmic
HPM
Locator, Metal, Electronic
HPN
Magnet, Permanent
HPO
Magnet, Ac-Powered
HPP
Headlamp, Operating, Battery-Operated
HPQ
Headlamp, Operating, Ac-Powered
HPS
Unit, Cryophthalmic
HPY
Unit, Electrolysis, Battery-Powered, Ophthalmic
HQA
Unit, Cryotherapy, Ophthalmic
HQB
Photocoagulator And Accessories
HQC
Unit, Phacofragmentation
K
21
2241
QUATERA 700
K
20
3060
VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control
K
20
0207
xPORT S Lens Fragmentation System
K
20
0584
xPORT 304 (miCOR) System Lens Fragmentation System
K
19
3376
Visalis V500, Visalis S500
K
19
2418
Phacoemulsification Needle (Tip) and Irrigation Sleeve
K
19
1650
LEGION System
K
19
0875
EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
K
19
1933
COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal
K
19
1024
xPORT Lens Fragmentation System
K
17
0052
Stellaris Elite vision enhancement system
K
16
1794
CENTURION Vision System (Active SentryTM)
K
16
2342
Stellaris Elite Vision Enhancement System
K
16
0236
Dual Pump Pack
K
15
1636
AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control
K
15
1783
COMPACT INTUITIV Multiple-Use Pack
K
14
2877
EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)
K
13
3562
CATARHEX 3
K
13
3486
STELLARIS PC VISION ENHANCEMENT SYSTEM
K
13
3115
COMPACT INTUITIV; SYSTEM, WIRELESS REMOTE CONTROL, FOUR-BUTTON FOOT PEDAL, SINGLE-USE FLUIDICS PACK
K
13
3242
STELLARIS VISION ENHANCEMENT SYSTEM
K
12
1555
CENTURION VISION SYSTEM
K
12
2829
LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS
K
12
1721
LAMINAR FLOW PHACO TIPS AND IRRIGATION SLEEVE (21G, REUSABLE)
K
12
0732
LENSSX LASER SYSTEM
K
12
0912
INFINITI(R) VISION SYSTEM
K
11
1446
SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM
K
11
2425
INFINITI VISION SYSTEM EVERGREEN II AUTOSERT IOL INJECTOR HANDPIECE
K
11
1882
LAMINAR FLOW PHACO TIPS
K
11
1697
AMO WHITESTAR SIGNATURE PHACOEMULSIFICATION SYSTEM
K
10
3023
UNIT, PHACOFRAGMENTATION
K
10
1285
CONSTELLATION VISION SYSTEM
K
10
1325
STELLARIS PC VISION ENHANCEMENT SYSTEM
K
09
3210
AQUALASE CAPSULE WASH TIP
K
09
1915
FLUID ISOLATION DEVICE
K
09
1777
ALCON ULTRACHOPPER
K
08
2845
INFINITI VISION SYSTEM WITH OZIL IP
K
08
2473
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM
K
08
1877
ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
K
08
0803
VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551
K
08
2132
BAUSCH & LOMB D4600A AIR EXCHANGE LINE PACK
K
06
3583
ALCON VISION SYSTEM
K
07
3023
STERILS SINGLE-USE I/A HANDPIECES
K
06
3331
BAUSCH & LOMB NGX MICROSURGICAL SYSTEM
K
06
0366
THE AMO OPHTHALMIC SURGICAL SYSTEM
K
05
1186
MICROPULSE PHACOEMULSIFICATION SYSTEM
K
05
0648
SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK
K
04
1998
PHACO CHOP NEEDLES
K
03
3653
VENTURI PHACO PACK
K
03
0957
PERFECT CAPSULE
K
03
1404
DIGNITY OPHTHALMIC SURGICAL SYSTEM
K
02
2833
BENJAMIN ENVOY PHACO HANDPIECE
K
02
0527
HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
K
02
1566
INFINITI
K
02
0734
SURGE-FREE ASPIRATION ADAPTER
K
00
3638
MOJAVE CATARACT EXTRACTION SYSTEM
K
00
3512
LASER PACK I, LASER PACK II, PHACO PACK I, PHACO PACK II
K
00
2932
PHACOGARD
K
00
2031
PHACOFRAGMENTATION SYSTEM MEGATRON
K
00
2986
A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
K
00
2812
IRIS RETRACTING PHACOEMULSIFICATION SLEEVE
K
99
1852
OCUSYSTEM ART ADVANTAGE, MODEL 995
K
98
4143
FIBRA-SONICS PHACO III OR IIIP FRAGMENTATION SYSTEM
K
98
1989
THE WAVE DIGITAL PHACO SYSTEM
K
98
1103
TURBOSONICS LIMITED REUSE ULTRASONIC TIP
K
98
1109
QUITETIP
K
98
0480
SYNTEC VITMAN
K
98
0085
PHACO COMMANDER
K
97
4469
MENTOR PHACOEMULSIFICATION SISTEM REMOTE CONTROL
K
97
4719
PHACOPAK
K
97
3749
FRAG COMMANDER
K
97
2063
WHITTINGHAM ULTRACLEAN PHACO HANDPIECE
K
97
2252
VISTA UNIVERSAL HANDPIECE
K
97
2253
P3 UNIVERSAL PHACO HANDPIECE
K
97
1795
AUTOMATED CHAMBER MAINTENANCE MODULE
K
97
1750
WELCH ALLYN PHACO ILLUMINATOR
K
97
1439
STORZ MICROFLOW AND STORZ STANDARD PHACOEMULSIFICATION NEEDLES
K
97
1186
AMO DIPLOMAX/OPSYS CONSOLE
K
97
1064
BAYERS BIMANUAL I/A HANDPIECES
K
96
5127
DGH MODEL 9000
K
96
4018
PHACOILLUMINATOR - FIBEROPTIC SLEEVE
K
96
0287
HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM
K
96
0811
PHACOSCOPE
K
96
0024
STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH
K
96
2402
AMO PRESTIGE DAY PACK (ALLERGAN, INC.)
K
96
0003
STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION
K
96
2131
STORZ D4600 AIR EXCHANGE LINE PACK
K
96
1874
STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK
K
96
1831
STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK
K
96
1820
STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK
K
96
2431
CTM DISPOSABLE PAK
K
96
2430
CTM REUSABLE PAK
K
96
1658
MEGATRON OPHTHALMIC SURGICAL SYSTEM
K
96
1243
OCUSYSTEM ART ADVANTAGE
K
96
1310
STORZ PREMIERE II MICROSURGICAL SYSTEM (CX SERIES)
K
96
0414
SYNERGIST POWER PACK
K
95
5901
STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX
K
95
5789
ALCON SERIES 20000 LEGACY MACKOOL SYSTEM
K
95
5245
MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM
K
95
4746
PHACO TIP
K
95
3538
RM001 REUSABLE
K
95
3539
DM001 DISPOSABLE PACK
K
95
4340
STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE
K
95
4239
U.S. IOL PHACO HANDPIECE
K
95
4238
SURGIN GENISIS HANDPIECE
K
95
4237
CIRCUIT TREE PHACO HANDPIECE
K
95
4241
SURGIN GENISIS PHACOEMULSIFIER
K
95
4240
EVOLUTION PHACOMULSIFIER
K
95
4242
CIRCUIT TREE PHACOEMULSIFIER
K
95
3959
PHACO HANDPIECE FOR PHACO FRAGMENTATION MACHINES, PHACO SLEEVE FOR ATTACHMENT TO PHACO HANDPIECES
K
95
1463
STORZ I/A HANDPIECES
K
95
3359
TRI-STAR UNIVERSAL I/A PHACO PAK
K
95
3447
PRECISIONIST THIRTY THOUSAND
K
94
4993
IOLAB.SITE CD PHACOEMULSIFICATION MODULE
K
94
4995
IOLAB/SITE PERISTALTIC MODULE
K
95
0881
PHACO TIP
K
95
2468
HI-LINE MEDICAL PHACOEMULSIFIER TIP
K
95
2331
AOI LC-40 PHACOEMULSIFIER
K
95
2213
ALCON SERIES 20000 LEGACY PHACOEMULSIFIER
K
95
3078
STORZ DP4101 BASIC I/A PACK
K
95
1824
STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)
K
95
0218
OMS SLIMLINE PHACO HANDPIECE
K
94
6054
DIPLOMAX
K
95
1462
AMO PROFINESSE III ULTRASONIC HANDPIECE SYSTEM
K
95
2259
STORZ MICROSEAL DP8030 & DP8045 PHACOEMULSIFICATION NEEDLES
K
95
0114
STOTZ PROTEGE(TM) MICROSURGICAL SYSTEM
K
95
0880
AOI UNIVERSAL ULTRASONIC HANDPIECE
K
95
0798
POSTERIOR CAPSULE SHIELD
K
95
0800
PRO-PAK FOR OMS DIPLOMATE
K
95
0600
VACUUM SURGE SUPRESSER
K
94
6227
STORZ PREMIERE(R) MICROSURGICAL SYSTEM
K
94
4994
IOLAB/SITE DISPOSABLE DIAPHRAGM CASSETTE
K
94
6176
STORZ PHACOEMULSIFICATION NEEDLES
K
94
5583
OCUSYSTEM(ART)
K
94
2945
CASSETTE SYSTEM FOR STORZ
K
93
5926
STORZ PHACO AND FRAG HANDPIECES
K
94
3672
PHACO NEEDLES AND TIPS
K
94
3379
PHACO TIPS FOR PHACO FRAGMENTATION MACHINES
K
94
0083
STANDARD PHACO TIP 15, 30, 45, 60
K
94
0088
MEDICAL TECHNICAL PRODUCTS STANDARD ULTRASONIC HANDPIECE
K
94
3102
HIGH PERFORMANCE TIPS
K
94
2515
PHACO KIT
K
94
2517
10-K CASSETTE
K
94
2518
CASSETTE SYSTEM FOR SITE
K
94
2516
10-0 CASSETTE
K
94
0084
MODEL 2000 OPHTHALMIC SURGICAL SYSTEM
K
92
3630
PHACO NEEDLES 1000-R & 1000-O NEEDLES
K
93
5223
OPHTHALMIC SURGICAL SYSTEM
K
93
1358
AORP4000 REUSABLE PAK
K
93
1354
P4000 PHACOEMULSIFIER
K
92
5828
MODIFIED SITE TXR SYSTEMS
K
93
3627
PHACOFRAGMENTOR TIP
K
93
1357
AOD4000 DISPOSABLE PAK
K
93
3503
PRO-PHACO HANDPIECE
K
92
6381
OCUSYSTEM IIE
K
93
1866
SITE'S CD II PHACOEMULSIFICATION HANDPIECE
K
92
6512
STORZ MODIFIED PHACO NEEDLE WITH INSULATION SLEEVE
K
92
5631
PHACOTRON GOLD MULTIFUNCTION ULTRASONIC HANDPIECE
K
92
4260
NIDEK CV-12000
K
92
3725
OPHTHALMIC PHARCO NEEDLE
K
92
5254
AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38
K
92
4235
AMO ELITE
K
92
4033
ALTEX MODEL UST-3000E
K
92
2595
MODIFIED SITE MACROBORE PHACO NEEDLE
K
92
1607
IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE
K
91
2904
MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM
K
92
1135
IOLAB POWER I.V. POLE
K
91
5457
PHACO 20/20 SYSTEM I
K
91
5456
PHACO 3000 LINEAR
K
91
5118
PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE
K
91
4229
PHACO TIP
K
91
2902
PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE
K
91
4172
KPE 230 AM
K
91
3530
LOOK VISCODISSECTOR
K
91
2739
SITE 90 TIP, I/A HANDPIECE .3MM SIDE OPEN/OPTH USE
K
91
1808
GEMINI OPHTHALMIC SURGERY SYSTEM
K
90
4612
I/A-PHACO SYSTEM (IRR./ASPIR./AND PHACO./SYSTEM)
K
90
4183
SITE PHACOEMULSIFICATION HANDPIECE
K
90
4151
SITE 19 GAUGE ULTRASONIC I/A PHACO NEEDLE
K
90
2876
PHACOTRON SYSTEMS PLUS III PHACOEMULSIFIER ASPI.
K
90
2798
AUTOMATED HYDROSONICS(TM)
K
90
0493
THE PRECISIONIST
K
90
2150
PIEZO HANDPIECE
K
90
1686
NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000
K
89
4512
PHACOEMULSIFICATION UNIT TO REMOVE CATARAC. LENS
K
89
4511
MAGNETRON MUNICH MODEL ELECTRONIC CONTROL UNIT
K
89
2852
SITE PHACO PLUS INFUSION SLEEVE
K
89
1161
VITRECTOMY PACK #J120
K
89
0825
JUMPER PACK #203
K
89
2911
SITE PERISTALTIC CASSETTE
K
89
0635
CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.
K
89
0080
PHACOEMULSIFIER MODEL 100
K
88
4241
STAAR PHACO XL SMALL INCISION SYSTEM
K
88
3097
GV3000 PHACOEMULSIFIER/FRAGMENTER
K
88
3199
MODIFICATION TO THE SITE PERISTALTIC MODULE SYSTEM
K
88
3099
SITE MACROBORE PHACO NEEDLE
K
88
2103
SITE ULTRASONIC I/A PHACO NEEDLE
K
88
1635
NOETIX(R) SURGICAL EXTRACTION(TM) SYSTEM
K
88
0062
C-MATE #CMU 1001
K
87
4334
SOLOS SINGLE USE TITANIUM TIP
K
87
2611
SOLOS EYESITE CAP SLEEVE
K
87
1473
PART #860065 IA PAK & PART #860060 IA PAK
K
87
2362
FRIGITRONICS ACC-1000 CAPSULE CUTTER
K
87
1854
IN-LINE OPHTHALMIC IRRIGATING SOLUTION FILTERS
K
87
1485
SITE PHACOEMULSIFICATION SYSTEM/OPHTHALMIC USE
K
87
1649
CLASSIC 70 LENS
K
87
0671
PHACOTRON DAY PAK
K
87
0806
NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100
K
86
4726
I/A/KPE TIP
K
86
4301
SITE PHACOEMULSIFICATION SYST/OPHTHALMIC USE (MOD)
K
86
4056
GRIESHABER AIR SYSTEM/PRESSURE OPHTHALMIC IRRIGANT
K
86
3444
GRIESHABER GLOBAL CONTROL TUBING SET
K
86
3729
OPHTHALMIC FITLER MICRO CAPSULE
K
86
3209
US PLUS-PAK(R) SURGICAL SYSTEM
K
86
2777
MODEL A-8000 ULTRASONIC HANDPIECE CORD
K
86
2021
PHACOEMULSIFICATION ULTRASONIC FRAGMENT SYSTEM
K
86
2064
ENTRAVISION EP-500 I/A ECCO PACK
K
86
2063
ENTRAVISION MODECO II I/A MACHINE & I/A HANDPIECE
K
86
0956
KANSAS I/A SYSTEM & KANSAS I/A & VITRECTROMY SYST.
K
86
0957
DISPOSABLE ACCESSORIES FOR I/A SYS. & VITEOUS CUT.
K
86
1060
SITE PHACO DISPOSABLE CASSETTE
K
86
0989
SITE DISPOSABLE CASSETTE
K
86
0770
AM-100 I/A AMPAC
K
85
4375
COOPERVISION ACAP POWER DRIVE ULTRASONIC ANTERIOR
K
85
4225
ALLERGAN I.S.P. MODEL 3000 OPHTHALMIC SURGICAL-SYS
K
85
4116
PHACO PACKS, 1A PACKS & PACK COMPONENTS
K
84
4373
O.M.S. ULTRA-PHACO
K
85
3883
TUBING A VIT, VIT, FRAG PACKS & NEEDLE & CLEAN WIR
K
85
3189
CREAT BRAND I/A PACK CREAT BRAND PHACO PACK
K
85
3070
COOPER VISION SYSTEM VI U/S MODULE
K
85
2208
PHACO-BAC STOP FILTER KIT
K
85
1674
PHAKOSYSTEMS MODEL CES 4100
K
85
1211
PHACO PAK I
K
85
1212
UNITED SONICS PACO SYSTEM MODEL 3000
K
85
1209
CILCO/UNITED SONICS PHACE PF-9000
K
85
1210
UNITED SONICS PHACO MODULE, DF-35
K
85
1298
MID LABS MVSXI
K
84
3276
IOCARE CONVERTER KIT
K
85
0532
ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACK
K
85
0275
KCP PAK #2 CONVENIENCE PACK MODIFICATION
K
85
0148
KCP PAK CONVENIENCE PACK
K
85
0149
KCP (KELMAN COMPACT PHACO-EMULSIFIER) PEA
K
85
1009
INFUSION SLEEVE - OPHTHALMIC
K
85
0578
PHACOEMULSIFICATION TIP
K
85
0899
I/A BAC STOP KIT
K
85
0900
PHACO-BAC STOP KIT
K
84
3487
VISITEC OPHTHALMIC FLUID DISTRIB- SET
K
84
3319
CILCO I/A SURGICAL PACK
K
84
4666
SITE ULTRASONIC EMULSIFICATION MODULE OP
K
84
4150
MEDICAL OPTICS PHACOEMULSIFICATION KIT
K
84
2945
COOPERVISION SYSTEM VI
K
84
3386
MENDEZ U/S CYSTOTOME
K
84
3278
IOCARE ULTRASONIC TITANIUM TIPS
K
84
3277
IOCARE PHACOEMULSIFICATION PACK
K
84
3275
IOCARE IRRIGATION/ASPIRATION PACK
K
84
2979
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA
K
84
0181
CATAREX/ULTRASONICS KIT
K
84
0063
CATAREX VITRECUTTER I/A DISPOS. CUT
K
84
2458
SITE SIMCOE STYLE I/A HANDPIECE
K
84
0495
MANUAL IRRIGATING/ASPIRATING UNIT
K
84
0695
PHACOEMULSIFICATION KITS
K
84
0965
SITE COAXIAL I/A HANDPIECE 30 TIP
K
83
4340
IOCARE IRRIGATION & ASPIRATION PACK
K
84
1072
IRRIGATION, ASPIRATION TUBING SETS
K
83
4453
PHACO FRAGMENTOR GT-1
K
83
4537
MICRO VIT FRAGMENTATION SYSTEM
K
83
4543
OCUCARE ULTRASOUND TIP & FREEDOM PACK
K
83
4261
PLASTIC OPTICAL LENS M-110
K
83
3465
DISPOSABLE FIBER OPTIC ILLUMINATOR
K
83
3962
KPE PLUS-PAK SURGICAL SYSTEM
K
83
3961
I/A PLUS PAK SURGICAL SYSTEM
K
83
3783
DISPOS. I/A & IRRIGATION HANDPIECES
K
83
3642
PHAKO SYSTEMS VIA 2000
K
83
3784
DISPOSABLE I/A HANDPIECE
K
83
3405
IRRIGATION ASPIRATION KIT
K
83
3800
BEECHER 20 GA. PROBE
K
83
3064
STORZ EXTRA
K
83
2529
M.S.D. ASPIRATOR
K
83
3697
EXTRA SENSORY PAK-DISPOS. ACCESS
K
83
3617
EXTRA PLUS TM
K
83
4161
UNIVERSAL PAC
K
83
4159
PHACOTRON PLUS
K
83
4158
EXTRA SENSORY PLUS
K
83
2980
VXTRA OCUTOME KIT
K
83
2997
EPA AUTOMATED INFUSION POLE
K
83
2413
SIAS IRRIGATION/ASPIRATION SYSTEM
K
83
2559
OCUCARE FREEDOM PACK
K
83
2423
ENVISION G21 I/A ENPAK
K
83
2424
ENVISION G31 P.E. PAK
K
83
1701
UNIVERSAL PACK
K
83
1836
EPSILON ULTRASONIC TIP
K
83
1172
ULTRAKIT
K
83
0812
ALPHAMEDIX I/A HAND-PIECE, 500-001
K
83
0902
OCUCARE PACK
K
82
3088
ASPITRON
K
83
0474
IV STAND
K
83
0385
IRRIGATION/ASPIRATION KIT
K
83
0379
PHAKO KIT
K
81
2126
ULTRASONIC TIPS
K
80
2381
LEWICKY ANTERIOR CHAMBER MAINTEN. SYS.
K
78
2141
LEVIGATOR, KEELER PHOKO
K
77
1644
FRAGMATOME MODEL 820
HQE
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
HQF
Laser, Ophthalmic
HQO
Unit, Cautery, Thermal, Ac-Powered
HQP
Unit, Cautery, Thermal, Battery-Powered
HQQ
Apparatus, Cautery, Radiofrequency, Battery-Powered
HQR
Apparatus, Cautery, Radiofrequency, Ac-Powered
HQS
Burr, Corneal, Ac-Powered
HRF
Engine, Trephine, Accessories, Battery-Powered
HRG
Engine, Trephine, Accessories, Ac-Powered
HRH
Trephine, Manual, Ophthalmic
HRJ
Table, Instrument, Powered, Ophthalmic
HRK
Table, Instrument, Manual, Ophthalmic
HRN
Unit, Cryophthalmic, Ac-Powered
HRO
Unit, Electrolysis, Ac-Powered, Ophthalmic
HRP
Pen, Marking, Surgical
KYB
Lens, Guide, Intraocular
KYG
Device, Irrigation, Ocular Surgery
LCC
Applicator, Ocular Pressure
LPO
Gases Used Within Eye To Place Pressure On Detached Retina
LQJ
Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
LWL
Fluid, Intraocular
LXP
Plug, Scleral
LXS
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
LZP
Aid, Surgical, Viscoelastic
MLZ
Vitrectomy, Instrument Cutter
MMC
Dilator, Expansive Iris (Accessory)
MOE
Collagen Corneal Shield
MSR
Tubing, Replacement, Phacofragmentation Unit
MSS
Folders And Injectors, Intraocular Lens (Iol)
MUS
Fluidic, Phacoemulsification/Phacofragmentation
MXO
Laser, System, Phacolysis
MXY
Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal
MYD
Keratome, Water Jet
NCE
Injector, Capsular Tension Ring
NCR
Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered
NGY
Cannula, Trocar, Ophthalmic
NKX
Needle, Phacoemulsification, Reprocessed
NKY
Blade, Keratome, Reprocessed
NLA
Knife, Ophthalmic, Reprocessed
NVB
Intraocular, Pressure Measuring Device
OHW
Burr, Corneal, Battery Powered, Rust Ring Removal
OHX
Burr, Corneal, Ac-Powered, Rust Ring Removal
OJK
Eye Tray
OOE
Ophthalmic Femtosecond Laser
OTZ
Graft Insertion Instrument For Endothelial Keratoplasty
PUL
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
PZG
Surgical Eye Tray
QDV
Iol Tray
QDW
Phaco Kit
QDY
Vitrectomy Kit
QGJ
Corneal Inlay Inserter Handle
QQQ
Guide And Positioner, Ophthalmic Drug Delivery Device
PYU
Sponge, Eyelid Cleaning, Powered
Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
surgical-devices
/
HQC
/
K833783
View Source
DISPOS. I/A & IRRIGATION HANDPIECES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K833783
510(k) Type
Traditional
Applicant
COOPERVISION, INC.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
3/5/1984
Days to Decision
129 days