FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—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
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
K
24
2389
EyeGility™ Inserter for Preloaded enVista IOLs
1
Cleared 510(K)
K
23
1106
Accuject Refra Injector AR2900
1
Cleared 510(K)
K
23
1838
RxSight® Insertion Device (63002)
1
Cleared 510(K)
K
23
1466
RxSight Insertion Device
1
Cleared 510(K)
K
21
2039
CLAREON MONARCH IV IOL Delivery System
1
Cleared 510(K)
K
20
0057
bioli lOL Delivery System
1
Cleared 510(K)
K
19
2926
RxSight Insertion Device
1
Cleared 510(K)
K
19
2005
Bausch + Lomb PreVue Inserter for enVista Preloaded
1
Cleared 510(K)
K
19
1949
UNFOLDER Vitan Inserter
1
Cleared 510(K)
K
18
2965
BL-Cart IOL Delivery Cartridge
1
Cleared 510(K)
K
18
1401
RxSight Insertion Device
1
Cleared 510(K)
K
17
2228
pioli IOL Delivery System
1
Cleared 510(K)
K
17
3480
Crystalsert Lens Delivery System
1
Cleared 510(K)
K
17
2375
MicroSTAAR Injector System Cartridges
1
Cleared 510(K)
K
16
1776
Lenstec LC Injection system
1
Cleared 510(K)
K
16
1012
Easy-Load Lens Delivery System
1
Cleared 510(K)
K
15
1102
Bausch + Lomb Injector System
1
Cleared 510(K)
K
14
3434
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
1
Cleared 510(K)
K
14
2056
LIOLI IOL DELIVERY SYSTEM
1
Cleared 510(K)
K
14
3307
RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector
1
Cleared 510(K)
K
14
1091
RAYSERT PLUS INJECTOR
1
Cleared 510(K)
K
13
2002
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
1
Cleared 510(K)
K
13
1958
BAUSCH & LOMB INJECTOR SYSTEM
1
Cleared 510(K)
K
13
3146
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
1
Cleared 510(K)
K
13
2481
EASY-LOAD LENS DELIVERY SYSTEM
1
Cleared 510(K)
K
12
2848
LENSTEC LC INJECTION SYSTEM
1
Cleared 510(K)
K
13
2593
CRYSTALSERT DELIVERY SYSTEM
1
Cleared 510(K)
K
12
3736
CRYSTALSERT DELIVERY SYSTEM
1
Cleared 510(K)
K
12
3888
Z CARTRIDGE IOL DELIVERY SYSTEM
1
Cleared 510(K)
K
11
3852
BAUSCH & LOMB IOL INJECTOR
1
Cleared 510(K)
K
11
2977
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
1
Cleared 510(K)
K
10
1774
MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
1
Cleared 510(K)
K
10
3495
ASICO SOFTIP INJECTOR SYSTEM
1
Cleared 510(K)
K
10
1782
MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE
1
Cleared 510(K)
K
10
1134
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
1
Cleared 510(K)
K
09
1507
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
1
Cleared 510(K)
K
09
2023
NAVIJECT SUB2-1P, MODEL: LP604430
1
Cleared 510(K)
K
08
2871
XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
1
Cleared 510(K)
K
09
0161
EPIPHANY INJECTION SYSTEM
1
Cleared 510(K)
K
08
1346
HOYA IS INJECTOR SYSTEM
1
Cleared 510(K)
K
08
2944
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
1
Cleared 510(K)
K
08
1545
ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30
1
Cleared 510(K)
K
08
1455
RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
1
Cleared 510(K)
K
07
3591
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
1
Cleared 510(K)
K
07
3586
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
1
Cleared 510(K)
K
07
3010
ROYALE AE 9036 LSP INJECTOR
1
Cleared 510(K)
K
06
3802
LENSTEC LC INJECTION SYSTEM
1
Cleared 510(K)
K
06
2612
RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04
1
Cleared 510(K)
K
06
0995
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788
1
Cleared 510(K)
K
06
0533
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM
1
Cleared 510(K)
K
05
3176
DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797
1
Cleared 510(K)
K
05
2651
C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
1
Cleared 510(K)
K
05
0638
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
1
Cleared 510(K)
K
04
0837
MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE
1
Cleared 510(K)
K
02
4072
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM
1
Cleared 510(K)
K
02
3737
INJECTOR
1
Cleared 510(K)
K
01
1392
MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER
1
Cleared 510(K)
K
00
3768
MONARCH II IOL DELIVERY SYSTEM
1
Cleared 510(K)
K
00
2556
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
1
Cleared 510(K)
K
98
0696
FOAM TIP INJECTOR
1
Cleared 510(K)
K
97
0727
MPORT FOLDABLE LENS PLACEMENT SYSTEM
1
Cleared 510(K)
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
QUQ
Knife, Intraocular Pressure Lowering
2
Product Code
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 9 May 2025 at 11:05 pm
OP
/
subpart-e—surgical-devices
/
MSS
/
K002556
View Source
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002556
510(k) Type
Traditional
Applicant
PHARMACIA & UPJOHN CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/31/2000
Days to Decision
75 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Miscellaneous
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—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
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)
K
24
2389
EyeGility™ Inserter for Preloaded enVista IOLs
K
23
1106
Accuject Refra Injector AR2900
K
23
1838
RxSight® Insertion Device (63002)
K
23
1466
RxSight Insertion Device
K
21
2039
CLAREON MONARCH IV IOL Delivery System
K
20
0057
bioli lOL Delivery System
K
19
2926
RxSight Insertion Device
K
19
2005
Bausch + Lomb PreVue Inserter for enVista Preloaded
K
19
1949
UNFOLDER Vitan Inserter
K
18
2965
BL-Cart IOL Delivery Cartridge
K
18
1401
RxSight Insertion Device
K
17
2228
pioli IOL Delivery System
K
17
3480
Crystalsert Lens Delivery System
K
17
2375
MicroSTAAR Injector System Cartridges
K
16
1776
Lenstec LC Injection system
K
16
1012
Easy-Load Lens Delivery System
K
15
1102
Bausch + Lomb Injector System
K
14
3434
One Series ULTRA Cartridge, The UNFOLDER Platinum 1 Series
K
14
2056
LIOLI IOL DELIVERY SYSTEM
K
14
3307
RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector
K
14
1091
RAYSERT PLUS INJECTOR
K
13
2002
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR
K
13
1958
BAUSCH & LOMB INJECTOR SYSTEM
K
13
3146
BAUSCH + LUMB, VIS100 INJECTOR SYSTEM
K
13
2481
EASY-LOAD LENS DELIVERY SYSTEM
K
12
2848
LENSTEC LC INJECTION SYSTEM
K
13
2593
CRYSTALSERT DELIVERY SYSTEM
K
12
3736
CRYSTALSERT DELIVERY SYSTEM
K
12
3888
Z CARTRIDGE IOL DELIVERY SYSTEM
K
11
3852
BAUSCH & LOMB IOL INJECTOR
K
11
2977
MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4)
K
10
1774
MONARCH III IOL DELIVERY SYSTEM; MONARCH III P CATRIDGE; MONARCH III HANDPIECE (H4)
K
10
3495
ASICO SOFTIP INJECTOR SYSTEM
K
10
1782
MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE
K
10
1134
VISIAN NANOPOINT 2.0 INJECTOR MODEL LP604430
K
09
1507
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18
K
09
2023
NAVIJECT SUB2-1P, MODEL: LP604430
K
08
2871
XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM
K
09
0161
EPIPHANY INJECTION SYSTEM
K
08
1346
HOYA IS INJECTOR SYSTEM
K
08
2944
CRYSTALSERT CRYSTALENS DELIVERY SYSTEM
K
08
1545
ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30
K
08
1455
RAYNER SINGLE USE SMALL INCISION DISPOSABLE INJECTOR, MODEL R-INJ-06
K
07
3591
MICROSTAAR MSI INJECTOR FOAM TIP SYSTEM
K
07
3586
MICROSTAAR INDIGO INJECTOR FOAM TIP SYSTEM
K
07
3010
ROYALE AE 9036 LSP INJECTOR
K
06
3802
LENSTEC LC INJECTION SYSTEM
K
06
2612
RAYNER SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, MODEL R-INJ-04
K
06
0995
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM, MODEL DK7788
K
06
0533
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM
K
05
3176
DUCKWORTH & KENT LTD CARTRIDGE LENS DELIVERY SYSTEM, MODEL DK7797
K
05
2651
C-FLEX SYSTEM SINGLE USE DISPOSABLE INJECTOR, MODEL R-INJ-02
K
05
0638
LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES
K
04
0837
MULTIJECT INJECTOR AND MICROGLIDE CARTRIDGE
K
02
4072
DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM
K
02
3737
INJECTOR
K
01
1392
MICRA LENS INJECTOR, MICRA CARTRIDGE LENS, MICRA LENS LOADER
K
00
3768
MONARCH II IOL DELIVERY SYSTEM
K
00
2556
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
K
98
0696
FOAM TIP INJECTOR
K
97
0727
MPORT FOLDABLE LENS PLACEMENT SYSTEM
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
QUQ
Knife, Intraocular Pressure Lowering
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
subpart-e—surgical-devices
/
MSS
/
K002556
View Source
CEEON EASYSERT INTRAOCULAR LENS INJECTOR, MODEL IMP-1
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K002556
510(k) Type
Traditional
Applicant
PHARMACIA & UPJOHN CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/31/2000
Days to Decision
75 days
Submission Type
Summary