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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
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
K
17
3371
VisuMax Femtosecond Laser
1
Cleared 510(K)
K
17
2994
EPI K Console
1
Cleared 510(K)
K
07
2102
EPIVISION SL SYSTEM
1
Cleared 510(K)
K
08
2043
CARRIAZO-PENDULAR MICROKERATOME
1
Cleared 510(K)
K
06
2465
ZYOPTIX XP EPI SEPARATOR SYSTEM
1
Cleared 510(K)
K
05
2891
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
1
Cleared 510(K)
K
05
1486
NORWOOD ABBEY CENTURION SES EPIKERATOME
1
Cleared 510(K)
K
04
3183
EPI-K
1
Cleared 510(K)
K
04
3150
AMADEUS II EPIKERATOME
1
Cleared 510(K)
K
04
2083
MODIFICATION TO VISITOME 20-10 MICROKERATOME
1
Cleared 510(K)
K
04
2810
CENTURION SES EPIKERATOME
1
Cleared 510(K)
K
04
1110
MB 105 MILLENNIUM BLADES
1
Cleared 510(K)
K
04
1206
EPITOME SYSTEM
1
Cleared 510(K)
K
03
2910
CARRIAZO PENDULAR
1
Cleared 510(K)
K
03
2836
M3 MICROKERATOME
1
Cleared 510(K)
K
03
3457
M2 COMPATIBLE MICROKERATOME BLADE
1
Cleared 510(K)
K
03
3236
PRIZM KERATOME BLADE, MODEL MK8512M2
1
Cleared 510(K)
K
04
0204
ZYOPTIX XP MICROKERATOME
1
Cleared 510(K)
K
03
3182
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
1
Cleared 510(K)
K
03
3293
MED-LOGICS, MODEL ML7090
1
Cleared 510(K)
K
03
2978
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
1
Cleared 510(K)
K
03
2297
DISPOSABLE N-PE MICKROKERATOME BLADES
1
Cleared 510(K)
K
03
1735
CENTURION SES EPIKERATOME
1
Cleared 510(K)
K
03
0401
DISPOSABLE M2-PE MICROKERATOME BLADES
1
Cleared 510(K)
K
03
0891
SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK
1
Cleared 510(K)
K
02
0482
KERATOME BLADE 200200 & 600600
1
Cleared 510(K)
K
02
2982
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
1
Cleared 510(K)
K
02
2716
MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
1
Cleared 510(K)
K
02
2205
DISPOSABLE N-PE MICROKERATOME BLADES
1
Cleared 510(K)
K
02
1640
HANSATOME EXCELLUS MICROKERATOME
1
Cleared 510(K)
K
02
0079
BLADEWORKS MICROKERATOME BLADE, MODEL 7061
1
Cleared 510(K)
K
01
4000
VISTITOME 20-10 MICROKERATOME
1
Cleared 510(K)
K
02
0122
MB 102 MILLENNIUM BLADES
1
Cleared 510(K)
K
01
1833
MB 103 MILLENNIUM BLADES
1
Cleared 510(K)
K
01
3337
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
1
Cleared 510(K)
K
01
1195
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
1
Cleared 510(K)
K
01
0872
ML BLADE, MODEL ML7030
1
Cleared 510(K)
K
01
0260
HANSATOME MICROKERATOME
1
Cleared 510(K)
K
00
3820
DISPOSABLE CB-PE MICROKERATOME BLADES
1
Cleared 510(K)
K
00
2515
MEDLOGICS ML 4000, MODEL 4000
1
Cleared 510(K)
K
00
3143
MILLENNIUM BLADES, MODEL MB101
1
Cleared 510(K)
K
00
2849
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
1
Cleared 510(K)
K
00
1464
DISPOSABLE H-PE MICROKERATOME BLADES
1
Cleared 510(K)
K
00
1176
DISPOSABLE MICROKERATOME BLADES-PE
1
Cleared 510(K)
K
00
1806
REFRACTIVE SURGERY BLADES
1
Cleared 510(K)
K
00
1144
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
1
Cleared 510(K)
K
99
3225
BLADEWORKS MICROKERATOME BLADE
1
Cleared 510(K)
K
99
3122
MSP M/K BLADE
1
Cleared 510(K)
K
99
4015
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
1
Cleared 510(K)
K
99
3190
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)
1
Cleared 510(K)
K
99
0227
ULTRASHAPER KERATOME
1
Cleared 510(K)
K
99
2978
RICROKERATOME BLADE
1
Cleared 510(K)
K
99
0900
MICROKERATOME, MODEL MK-2000
1
Cleared 510(K)
K
98
4540
KERAVISION VACUUM RING SYSTEM
1
Cleared 510(K)
K
98
1554
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)
1
Cleared 510(K)
K
98
0675
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME
1
Cleared 510(K)
K
98
3317
BARRON MICROKERATOME SYSTEM, MODEL B2000
1
Cleared 510(K)
K
98
1742
ONE UP DISPOSABLE KERATOME HEAD
1
Cleared 510(K)
K
98
1155
FLAPMAKER DISPOSABLE MICROKERATOME
1
Cleared 510(K)
K
98
1071
ML MICROKERATOME
1
Cleared 510(K)
K
98
0985
SCMD-1000
1
Cleared 510(K)
K
98
0508
KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400
1
Cleared 510(K)
K
98
0510
KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)
1
Cleared 510(K)
K
97
4598
MICROKERATOME OR THE MATE
1
Cleared 510(K)
K
98
0924
PLANCON MICROLAMELLAR KERATOME EVOLUTION
1
Cleared 510(K)
K
97
4004
AUTOMATED DISPOSABLE KERATOME (ADK)
1
Cleared 510(K)
K
97
2808
HANSATOME MICROKERATOME
1
Cleared 510(K)
K
97
2727
CBALK-1000 BLADE
1
Cleared 510(K)
K
97
3294
INNOVATOME MICROKERATOME
1
Cleared 510(K)
K
97
0377
PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
1
Cleared 510(K)
K
96
2661
ML MICROKERATOME BLADE
1
Cleared 510(K)
K
96
0395
PLANCON MIRCOLAMELLAR KERATOME
1
Cleared 510(K)
K
95
4058
BARRAQUER-KRUMEICH REFRACTIVE SET
1
Cleared 510(K)
K
94
1550
AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT
1
Cleared 510(K)
K
93
5342
SCMD KERATOME
1
Cleared 510(K)
K
91
3697
AUTOMATIC CORNEAL SHAPER
1
Cleared 510(K)
K
91
1062
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
1
Cleared 510(K)
K
90
4845
STORZ DRAEGER ROTOR KERATOME
1
Cleared 510(K)
K
90
3912
KERATOME
1
Cleared 510(K)
K
87
0807
BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE
1
Cleared 510(K)
K
86
4065
BKS-42 DISPOSABLE VACUUM TUBING PACK
1
Cleared 510(K)
K
86
0001
BARRAQUER-KRUMEICH REFRACTIVE SET
1
Cleared 510(K)
K
76
0726
ELECTRO-KERATOTOME, LINE-OPERATED
1
Cleared 510(K)
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
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
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 2 June 2023 at 11:04 pm
OP
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surgical-devices
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HNO
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K760726
View Source
ELECTRO-KERATOTOME, LINE-OPERATED
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K760726
510(k) Type
Traditional
Applicant
STORZ INSTRUMENT CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/5/1976
Days to Decision
8 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
K
17
3371
VisuMax Femtosecond Laser
K
17
2994
EPI K Console
K
07
2102
EPIVISION SL SYSTEM
K
08
2043
CARRIAZO-PENDULAR MICROKERATOME
K
06
2465
ZYOPTIX XP EPI SEPARATOR SYSTEM
K
05
2891
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM
K
05
1486
NORWOOD ABBEY CENTURION SES EPIKERATOME
K
04
3183
EPI-K
K
04
3150
AMADEUS II EPIKERATOME
K
04
2083
MODIFICATION TO VISITOME 20-10 MICROKERATOME
K
04
2810
CENTURION SES EPIKERATOME
K
04
1110
MB 105 MILLENNIUM BLADES
K
04
1206
EPITOME SYSTEM
K
03
2910
CARRIAZO PENDULAR
K
03
2836
M3 MICROKERATOME
K
03
3457
M2 COMPATIBLE MICROKERATOME BLADE
K
03
3236
PRIZM KERATOME BLADE, MODEL MK8512M2
K
04
0204
ZYOPTIX XP MICROKERATOME
K
03
3182
PRIZM KERATOME BLADE (B.D. MODEL), MODEL MK8530BD
K
03
3293
MED-LOGICS, MODEL ML7090
K
03
2978
MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME
K
03
2297
DISPOSABLE N-PE MICKROKERATOME BLADES
K
03
1735
CENTURION SES EPIKERATOME
K
03
0401
DISPOSABLE M2-PE MICROKERATOME BLADES
K
03
0891
SURGISTAR MICROKERATOME BLADE, MODEL NO. 2400-LSK
K
02
0482
KERATOME BLADE 200200 & 600600
K
02
2982
MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB
K
02
2716
MED-LOGICS MICROKERATOME BLADE, MODEL 7020CLB
K
02
2205
DISPOSABLE N-PE MICROKERATOME BLADES
K
02
1640
HANSATOME EXCELLUS MICROKERATOME
K
02
0079
BLADEWORKS MICROKERATOME BLADE, MODEL 7061
K
01
4000
VISTITOME 20-10 MICROKERATOME
K
02
0122
MB 102 MILLENNIUM BLADES
K
01
1833
MB 103 MILLENNIUM BLADES
K
01
3337
PRIZM KERATOME BLADE (NIDEK MODEL), MODEL MK8514NI
K
01
1195
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB
K
01
0872
ML BLADE, MODEL ML7030
K
01
0260
HANSATOME MICROKERATOME
K
00
3820
DISPOSABLE CB-PE MICROKERATOME BLADES
K
00
2515
MEDLOGICS ML 4000, MODEL 4000
K
00
3143
MILLENNIUM BLADES, MODEL MB101
K
00
2849
PRECISIONEDGE-ACC, PRECISIONEDGE-ACS, PRECISIONEDGE-LSK, AND PRECISIONEDGE-CB MICROKEATOME BLADES
K
00
1464
DISPOSABLE H-PE MICROKERATOME BLADES
K
00
1176
DISPOSABLE MICROKERATOME BLADES-PE
K
00
1806
REFRACTIVE SURGERY BLADES
K
00
1144
ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS
K
99
3225
BLADEWORKS MICROKERATOME BLADE
K
99
3122
MSP M/K BLADE
K
99
4015
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508
K
99
3190
ADVANCED COMPUTER CONTROLLED MICROKERATOME-ACCM, MODEL SURGICAL INSTRUMENT SYSTEMS (SIS)
K
99
0227
ULTRASHAPER KERATOME
K
99
2978
RICROKERATOME BLADE
K
99
0900
MICROKERATOME, MODEL MK-2000
K
98
4540
KERAVISION VACUUM RING SYSTEM
K
98
1554
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI)
K
98
0675
SUMMIT KRUMEICH-BARRAQUER MICROKERATOME
K
98
3317
BARRON MICROKERATOME SYSTEM, MODEL B2000
K
98
1742
ONE UP DISPOSABLE KERATOME HEAD
K
98
1155
FLAPMAKER DISPOSABLE MICROKERATOME
K
98
1071
ML MICROKERATOME
K
98
0985
SCMD-1000
K
98
0508
KERATOME BLADE, CHIROM MODEL ALK 500500; KERATOME BLADE, S.C.M.D. MODEL TUROKERATOME 400400
K
98
0510
KERATOME BLADE (135 MICRON, MODEL 300135), (160 MICRON, MODEL 300160), (200 MICRON, MODEL 30020)
K
97
4598
MICROKERATOME OR THE MATE
K
98
0924
PLANCON MICROLAMELLAR KERATOME EVOLUTION
K
97
4004
AUTOMATED DISPOSABLE KERATOME (ADK)
K
97
2808
HANSATOME MICROKERATOME
K
97
2727
CBALK-1000 BLADE
K
97
3294
INNOVATOME MICROKERATOME
K
97
0377
PLANCON MICROLAMELLAR KERATOME (SINGLE PIECE KERATOME HEAD WITH ACCESSORIES)
K
96
2661
ML MICROKERATOME BLADE
K
96
0395
PLANCON MIRCOLAMELLAR KERATOME
K
95
4058
BARRAQUER-KRUMEICH REFRACTIVE SET
K
94
1550
AUTOMATIC CORNEAL SHAPER SURGICAL INSTRUMENT
K
93
5342
SCMD KERATOME
K
91
3697
AUTOMATIC CORNEAL SHAPER
K
91
1062
QUALITATIVE KERATOMETER M823 WITH POWER SUPPLY
K
90
4845
STORZ DRAEGER ROTOR KERATOME
K
90
3912
KERATOME
K
87
0807
BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE
K
86
4065
BKS-42 DISPOSABLE VACUUM TUBING PACK
K
86
0001
BARRAQUER-KRUMEICH REFRACTIVE SET
K
76
0726
ELECTRO-KERATOTOME, LINE-OPERATED
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)
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
/
HNO
/
K760726
View Source
ELECTRO-KERATOTOME, LINE-OPERATED
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K760726
510(k) Type
Traditional
Applicant
STORZ INSTRUMENT CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/5/1976
Days to Decision
8 days