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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
Diagnostic Devices
CFR Sub-Part
HKX
Tonometer, Ac-Powered
2
Product Code
HKY
Tonometer, Manual
2
Product Code
HKZ
Sterilizer, Tonometer
1
Product Code
HLA
Calibrator, Tonometer
2
Product Code
HLC
Instrument, Measuring, Stereopsis
1
Product Code
HLE
Ruler, Nearpoint (Punctometer)
1
Product Code
HLF
Device, Measuring, Lens Radius, Ophthalmic
1
Product Code
HLG
Pupillometer, Ac-Powered
1
Product Code
HLH
Pupillometer, Manual
1
Product Code
HLI
Ophthalmoscope, Ac-Powered
2
Product Code
HKM
Retinoscope, Battery-Powered
1
Product Code
HKN
Refractor, Manual, Non-Powered, Including Phoropter
1
Product Code
HKO
Refractometer, Ophthalmic
1
Product Code
HKQ
Prism, Rotary, Ophthalmic
1
Product Code
HKR
Lens, Maddox
1
Product Code
HKS
Prism, Gonioscopic
1
Product Code
HKT
Prism, Fresnel, Ophthalmic
1
Product Code
HKW
Prism, Bar, Ophthalmic
1
Product Code
KYH
Endoscope, Ophthalmic
2
Product Code
MPA
Endoilluminator
2
Product Code
NKZ
Endoilluminator, Reprocessed
2
Product Code
HIT
Tester, Color Vision
1
Product Code
HIW
Anomaloscope
1
Product Code
HIX
Maxwell Spot, Ac-Powered
1
Product Code
HIY
Brush, Haidinger, (Including Macular Integrity)
1
Product Code
HJA
Photokeratoscope
1
Product Code
HJB
Instrument, Measuring, Corneal Radius
1
Product Code
HJC
Esthesiometer, Ocular
1
Product Code
HJD
Illuminator, Color Vision Plate
1
Product Code
HJI
Lens, Fundus, Hruby, Diagnostic
1
Product Code
HJJ
Lens, Fresnel, Flexible, Diagnostic
1
Product Code
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
2
Product Code
K
20
1909
RxSight Contact Lens
2
Cleared 510(K)
K
17
3944
Endocular Viewing Lenses and Silicone Ring
2
Cleared 510(K)
K
15
1961
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
2
Cleared 510(K)
K
14
2715
Sensor Medical Family of Vitrectomy Lenses and Products
2
Cleared 510(K)
K
05
1630
SUPER VIEW DISPOSABLE BIOM LENS SET
2
Cleared 510(K)
K
05
1103
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
2
Cleared 510(K)
K
05
0623
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
2
Cleared 510(K)
K
03
3950
DORC VITRECTOMY LENSES, MODEL 1284 SERIES
2
Cleared 510(K)
K
03
0054
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
2
Cleared 510(K)
K
02
3221
CONTACT LASER & DIAGNOSTIC LENSES
2
Cleared 510(K)
K
02
2413
LUNEAU 3 MIRROR LENS
2
Cleared 510(K)
K
01
4170
STAURENGHI WIDE FIELD SCANNING LASER LENS
2
Cleared 510(K)
K
01
2096
DISPOSABLE VITRECTOMY LENS
2
Cleared 510(K)
K
97
1853
ENDOVIEW SPPHIRE LENS SET
2
Cleared 510(K)
K
93
3976
MANDELKORN SUTURE LYSIS LENS
2
Cleared 510(K)
K
93
3264
RITCH NYLON SUTURE LASER LENS
2
Cleared 510(K)
K
94
0107
VIRECTOMY LENS
2
Cleared 510(K)
K
94
3125
QUADRASPHERIC FUNDUS LENS
2
Cleared 510(K)
K
94
1420
50 DEGREE HRI PRISM LENS
2
Cleared 510(K)
K
91
4051
PEDIATRIC VITRECTOMY LENS SET
2
Cleared 510(K)
K
91
4117
LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET
2
Cleared 510(K)
K
91
2366
MAINSTER HIGH MAGNIFICATION LASER LENS
2
Cleared 510(K)
K
91
0231
NMR-K FUNDUS LASER LENS
2
Cleared 510(K)
K
89
6198
MAINSTER WIDE FIELD LASER LENS
2
Cleared 510(K)
K
89
4421
WOLDOFF PRISMATIC BICONCAVE LENS
2
Cleared 510(K)
K
87
5331
BICONCAVE VITRECTOMY LENS
2
Cleared 510(K)
K
87
5330
HOSKINS-BARKAN GONIOTOMY LENS 10MM
2
Cleared 510(K)
K
87
5114
HOSKINS-BARKAN GONIOTOMY LENS 9MM
2
Cleared 510(K)
K
87
5087
PEYMAN G. 12.12 YAG LASER LENS
2
Cleared 510(K)
K
87
2855
18MM PEYMAN WIDE FIELD YAG LASER LENS
2
Cleared 510(K)
K
87
2136
12.5MM PEYMAN WIDE FIELD YAG LASER LENS
2
Cleared 510(K)
K
87
1450
25MM PEYMAN WIDE FIELD YAG LASER LENS
2
Cleared 510(K)
K
86
4304
YANNUZZI FUNDUS LASER LENS
2
Cleared 510(K)
K
86
3911
MAINSTER RETINA LASER LENS
2
Cleared 510(K)
K
86
4418
LANDERS INDIRECT VITRECTOMY LENS
2
Cleared 510(K)
K
86
3027
SCHIRMER PERIPHERAL IRIDECTOMY LASER LENS
2
Cleared 510(K)
K
86
2868
ABRAHAM YAG LASER LENS
2
Cleared 510(K)
K
86
2728
HOSKINS NYLON SUTURE LASER LENS
2
Cleared 510(K)
K
86
2094
LENS-EZE
2
Cleared 510(K)
K
86
1648
WISE IRIDOTOMY-SPINCTEROTOMY LENS
2
Cleared 510(K)
K
78
1960
SURGICAL EYE SHIELD
2
Cleared 510(K)
HJL
Lens, Condensing, Diagnostic
1
Product Code
HJM
Transilluminator, Ac-Powered
2
Product Code
HJN
Transilluminator, Battery-Powered
1
Product Code
HJO
Biomicroscope, Slit-Lamp, Ac-Powered
2
Product Code
HJQ
Stereoscope, Ac-Powered
1
Product Code
HJR
Stereoscope, Battery-Powered
1
Product Code
HJS
Test, Spectacle Dissociation, Ac-Powered (Lancaster)
1
Product Code
HJT
Haploscope
1
Product Code
HJW
Adaptometer (Biophotometer)
1
Product Code
HKD
Tape, Nystagmus
1
Product Code
HKF
Mirror, Headband, Ophthalmic
1
Product Code
HKG
Fornixscope
1
Product Code
HKI
Camera, Ophthalmic, Ac-Powered
2
Product Code
HKL
Retinoscope, Ac-Powered
2
Product Code
HLJ
Ophthalmoscope, Battery-Powered
2
Product Code
HLK
Screen, Tangent, Target, Battery-Powered
1
Product Code
HLL
Monitor, Eye Movement
2
Product Code
HLM
Instrument, Measuring, Lens, Ac-Powered
1
Product Code
HLN
Gauge, Lens, Ophthalmic
1
Product Code
HLO
Test, Spectacle Dissociation, Battery-Powered (Lancaster)
1
Product Code
HLP
Target, Fusion And Stereoscopic
1
Product Code
HLQ
Keratoscope, Ac-Powered
1
Product Code
HLR
Keratoscope, Battery-Powered
1
Product Code
HLS
Exophthalmometer
1
Product Code
HLT
Preamplifier, Ac-Powered, Ophthalmic
2
Product Code
HLW
Preamplifier, Battery-Powered, Ophthalmic
2
Product Code
HLX
Photostimulator, Ac-Powered
2
Product Code
HLZ
Electrode, Corneal
2
Product Code
HMC
Monitor, Eye Movement, Diagnostic
2
Product Code
HMD
Chair, Ophthalmic, Manual
1
Product Code
HME
Chair, Ophthalmic, Ac-Powered
1
Product Code
HMF
Stand, Instrument, Ac-Powered, Ophthalmic
1
Product Code
HMG
Stand, Instrument, Ophthalmic, Non-Powered
1
Product Code
HMH
Rack, Skiascopic
1
Product Code
HMJ
Screen, Tangent, Projection, Battery-Powered
1
Product Code
HMK
Euthyscope, Ac-Powered
2
Product Code
HML
Euthyscope, Battery-Powered
1
Product Code
HMM
Distometer
1
Product Code
HOJ
Screen, Tangent, Target
1
Product Code
HOK
Screen, Tangent, Projection, Ac-Powered
1
Product Code
HOL
Screen, Tangent, Felt (Campimeter)
1
Product Code
HOM
Screen, Tangent, Ac-Powered (Campimeter)
1
Product Code
HON
Perimeter, Manual
1
Product Code
HOO
Perimeter, Ac-Powered
1
Product Code
HOP
Campimeter, Stereo, Battery-Powered
1
Product Code
HOQ
Grid, Amsler
1
Product Code
HOR
Simulatan (Including Crossed Cylinder)
1
Product Code
HOS
Projector, Ophthalmic
1
Product Code
HOW
Drum, Opticokinetic
1
Product Code
HOX
Chart, Visual Acuity
1
Product Code
HPA
Frame, Trial, Ophthalmic
1
Product Code
HPB
Clip, Lens, Trial, Ophthalmic
1
Product Code
HPC
Set, Lens, Trial, Ophthalmic
1
Product Code
HPD
Lens, Bagolini
1
Product Code
HPJ
Instrument, Visual Field, Laser
2
Product Code
HPK
Tonograph
2
Product Code
HPL
Device, Fixation, Ac-Powered, Ophthalmic
1
Product Code
HPT
Perimeter, Automatic, Ac-Powered
1
Product Code
HPW
Probe And Counter, Isotope, For Phosphorus 32
2
Product Code
HRE
Cabinet, Instrument, Ac-Powered, Ophthalmic
1
Product Code
HRI
Pupillograph
1
Product Code
KYD
Strip, Schirmer
1
Product Code
MMF
Photorefractor
2
Product Code
MMQ
Topographer, Corneal, Ac-Powered
1
Product Code
MSG
Ophthalmoscopes, Replacement Batteries, Hand-Held
2
Product Code
MXK
Device, Analysis, Anterior Segment
2
Product Code
MYC
Ophthalmoscope, Laser, Scanning
2
Product Code
NCF
Aberrometer, Ophthalmic
1
Product Code
NFD
Selector, Color, Spectacle, Lens, Tint
1
Product Code
NJG
Flasher, Afterimage, Ophthalmic
2
Product Code
NJJ
Tonometer, Analyzer, Ocular Blood Flow
2
Product Code
NOG
Topographer, Corneal, Battery Powered
1
Product Code
NOH
Photokeratoscope, Battery Powered
1
Product Code
NOI
Stand, Instrument, Ophthalmic, Battery Powered
1
Product Code
NQE
Microscope, Specular
2
Product Code
NXR
Fixation, Vision Training, Binocular
1
Product Code
NYK
Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
2
Product Code
OBO
Tomography, Optical Coherence
2
Product Code
OUM
Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
1
Product Code
PIB
Diabetic Retinopathy Detection Device
2
Product Code
PJZ
Camera, Ophthalmic, General-Use
2
Product Code
PLZ
Ocular Pattern Recorder
2
Product Code
PMW
Strabismus Detection Device
2
Product Code
PUE
Biomicroscope, Slit-Lamp, Ac-Powered, Exempt
2
Product Code
QER
Camera, Ophthalmic, Slit-Scanning
2
Product Code
NFF
Device, Storage, Images, Ophthalmic
1
Product Code
NFG
Device, Communications, Images, Ophthalmic
1
Product Code
NFH
Digitizer, Images, Ophthalmic
2
Product Code
NFI
Device, Hardcopy, Images, Ophthalmic
2
Product Code
NFJ
System, Image Management, Ophthalmic
2
Product Code
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
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
/
diagnostic-devices
/
HJK
/
K862094
View Source
LENS-EZE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K862094
510(k) Type
Traditional
Applicant
INSIGHT INTERNATIONAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/19/1986
Days to Decision
17 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
HKX
Tonometer, Ac-Powered
HKY
Tonometer, Manual
HKZ
Sterilizer, Tonometer
HLA
Calibrator, Tonometer
HLC
Instrument, Measuring, Stereopsis
HLE
Ruler, Nearpoint (Punctometer)
HLF
Device, Measuring, Lens Radius, Ophthalmic
HLG
Pupillometer, Ac-Powered
HLH
Pupillometer, Manual
HLI
Ophthalmoscope, Ac-Powered
HKM
Retinoscope, Battery-Powered
HKN
Refractor, Manual, Non-Powered, Including Phoropter
HKO
Refractometer, Ophthalmic
HKQ
Prism, Rotary, Ophthalmic
HKR
Lens, Maddox
HKS
Prism, Gonioscopic
HKT
Prism, Fresnel, Ophthalmic
HKW
Prism, Bar, Ophthalmic
KYH
Endoscope, Ophthalmic
MPA
Endoilluminator
NKZ
Endoilluminator, Reprocessed
HIT
Tester, Color Vision
HIW
Anomaloscope
HIX
Maxwell Spot, Ac-Powered
HIY
Brush, Haidinger, (Including Macular Integrity)
HJA
Photokeratoscope
HJB
Instrument, Measuring, Corneal Radius
HJC
Esthesiometer, Ocular
HJD
Illuminator, Color Vision Plate
HJI
Lens, Fundus, Hruby, Diagnostic
HJJ
Lens, Fresnel, Flexible, Diagnostic
HJK
Lens, Contact, Polymethylmethacrylate, Diagnostic
K
20
1909
RxSight Contact Lens
K
17
3944
Endocular Viewing Lenses and Silicone Ring
K
15
1961
Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
K
14
2715
Sensor Medical Family of Vitrectomy Lenses and Products
K
05
1630
SUPER VIEW DISPOSABLE BIOM LENS SET
K
05
1103
HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
K
05
0623
VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
K
03
3950
DORC VITRECTOMY LENSES, MODEL 1284 SERIES
K
03
0054
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
K
02
3221
CONTACT LASER & DIAGNOSTIC LENSES
K
02
2413
LUNEAU 3 MIRROR LENS
K
01
4170
STAURENGHI WIDE FIELD SCANNING LASER LENS
K
01
2096
DISPOSABLE VITRECTOMY LENS
K
97
1853
ENDOVIEW SPPHIRE LENS SET
K
93
3976
MANDELKORN SUTURE LYSIS LENS
K
93
3264
RITCH NYLON SUTURE LASER LENS
K
94
0107
VIRECTOMY LENS
K
94
3125
QUADRASPHERIC FUNDUS LENS
K
94
1420
50 DEGREE HRI PRISM LENS
K
91
4051
PEDIATRIC VITRECTOMY LENS SET
K
91
4117
LANDERS HIGH REFRACTIVE INDEX VITRECTOMY LENS SET
K
91
2366
MAINSTER HIGH MAGNIFICATION LASER LENS
K
91
0231
NMR-K FUNDUS LASER LENS
K
89
6198
MAINSTER WIDE FIELD LASER LENS
K
89
4421
WOLDOFF PRISMATIC BICONCAVE LENS
K
87
5331
BICONCAVE VITRECTOMY LENS
K
87
5330
HOSKINS-BARKAN GONIOTOMY LENS 10MM
K
87
5114
HOSKINS-BARKAN GONIOTOMY LENS 9MM
K
87
5087
PEYMAN G. 12.12 YAG LASER LENS
K
87
2855
18MM PEYMAN WIDE FIELD YAG LASER LENS
K
87
2136
12.5MM PEYMAN WIDE FIELD YAG LASER LENS
K
87
1450
25MM PEYMAN WIDE FIELD YAG LASER LENS
K
86
4304
YANNUZZI FUNDUS LASER LENS
K
86
3911
MAINSTER RETINA LASER LENS
K
86
4418
LANDERS INDIRECT VITRECTOMY LENS
K
86
3027
SCHIRMER PERIPHERAL IRIDECTOMY LASER LENS
K
86
2868
ABRAHAM YAG LASER LENS
K
86
2728
HOSKINS NYLON SUTURE LASER LENS
K
86
2094
LENS-EZE
K
86
1648
WISE IRIDOTOMY-SPINCTEROTOMY LENS
K
78
1960
SURGICAL EYE SHIELD
HJL
Lens, Condensing, Diagnostic
HJM
Transilluminator, Ac-Powered
HJN
Transilluminator, Battery-Powered
HJO
Biomicroscope, Slit-Lamp, Ac-Powered
HJQ
Stereoscope, Ac-Powered
HJR
Stereoscope, Battery-Powered
HJS
Test, Spectacle Dissociation, Ac-Powered (Lancaster)
HJT
Haploscope
HJW
Adaptometer (Biophotometer)
HKD
Tape, Nystagmus
HKF
Mirror, Headband, Ophthalmic
HKG
Fornixscope
HKI
Camera, Ophthalmic, Ac-Powered
HKL
Retinoscope, Ac-Powered
HLJ
Ophthalmoscope, Battery-Powered
HLK
Screen, Tangent, Target, Battery-Powered
HLL
Monitor, Eye Movement
HLM
Instrument, Measuring, Lens, Ac-Powered
HLN
Gauge, Lens, Ophthalmic
HLO
Test, Spectacle Dissociation, Battery-Powered (Lancaster)
HLP
Target, Fusion And Stereoscopic
HLQ
Keratoscope, Ac-Powered
HLR
Keratoscope, Battery-Powered
HLS
Exophthalmometer
HLT
Preamplifier, Ac-Powered, Ophthalmic
HLW
Preamplifier, Battery-Powered, Ophthalmic
HLX
Photostimulator, Ac-Powered
HLZ
Electrode, Corneal
HMC
Monitor, Eye Movement, Diagnostic
HMD
Chair, Ophthalmic, Manual
HME
Chair, Ophthalmic, Ac-Powered
HMF
Stand, Instrument, Ac-Powered, Ophthalmic
HMG
Stand, Instrument, Ophthalmic, Non-Powered
HMH
Rack, Skiascopic
HMJ
Screen, Tangent, Projection, Battery-Powered
HMK
Euthyscope, Ac-Powered
HML
Euthyscope, Battery-Powered
HMM
Distometer
HOJ
Screen, Tangent, Target
HOK
Screen, Tangent, Projection, Ac-Powered
HOL
Screen, Tangent, Felt (Campimeter)
HOM
Screen, Tangent, Ac-Powered (Campimeter)
HON
Perimeter, Manual
HOO
Perimeter, Ac-Powered
HOP
Campimeter, Stereo, Battery-Powered
HOQ
Grid, Amsler
HOR
Simulatan (Including Crossed Cylinder)
HOS
Projector, Ophthalmic
HOW
Drum, Opticokinetic
HOX
Chart, Visual Acuity
HPA
Frame, Trial, Ophthalmic
HPB
Clip, Lens, Trial, Ophthalmic
HPC
Set, Lens, Trial, Ophthalmic
HPD
Lens, Bagolini
HPJ
Instrument, Visual Field, Laser
HPK
Tonograph
HPL
Device, Fixation, Ac-Powered, Ophthalmic
HPT
Perimeter, Automatic, Ac-Powered
HPW
Probe And Counter, Isotope, For Phosphorus 32
HRE
Cabinet, Instrument, Ac-Powered, Ophthalmic
HRI
Pupillograph
KYD
Strip, Schirmer
MMF
Photorefractor
MMQ
Topographer, Corneal, Ac-Powered
MSG
Ophthalmoscopes, Replacement Batteries, Hand-Held
MXK
Device, Analysis, Anterior Segment
MYC
Ophthalmoscope, Laser, Scanning
NCF
Aberrometer, Ophthalmic
NFD
Selector, Color, Spectacle, Lens, Tint
NJG
Flasher, Afterimage, Ophthalmic
NJJ
Tonometer, Analyzer, Ocular Blood Flow
NOG
Topographer, Corneal, Battery Powered
NOH
Photokeratoscope, Battery Powered
NOI
Stand, Instrument, Ophthalmic, Battery Powered
NQE
Microscope, Specular
NXR
Fixation, Vision Training, Binocular
NYK
Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
OBO
Tomography, Optical Coherence
OUM
Adaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation
PIB
Diabetic Retinopathy Detection Device
PJZ
Camera, Ophthalmic, General-Use
PLZ
Ocular Pattern Recorder
PMW
Strabismus Detection Device
PUE
Biomicroscope, Slit-Lamp, Ac-Powered, Exempt
QER
Camera, Ophthalmic, Slit-Scanning
NFF
Device, Storage, Images, Ophthalmic
NFG
Device, Communications, Images, Ophthalmic
NFH
Digitizer, Images, Ophthalmic
NFI
Device, Hardcopy, Images, Ophthalmic
NFJ
System, Image Management, Ophthalmic
General Hospital and Personal Use Therapeutic Devices
Miscellaneous
Prosthetic Devices
Surgical Devices
Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
diagnostic-devices
/
HJK
/
K862094
View Source
LENS-EZE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K862094
510(k) Type
Traditional
Applicant
INSIGHT INTERNATIONAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
6/19/1986
Days to Decision
17 days