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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
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
K
19
3188
MiiS Horus Eye Anterior Camera
2
Cleared 510(K)
K
18
2306
Sunkingdom Slit Lamp
2
Cleared 510(K)
K
17
3771
IOLMaster 700
2
Cleared 510(K)
K
17
1877
SLM-1ER, SLM-2ER, SLM-3ER
2
Cleared 510(K)
K
17
0470
Digital Eye Anterior Camera
2
Cleared 510(K)
K
16
2778
Portable Slit Lamp Microscope
2
Cleared 510(K)
K
16
2684
SL 220
2
Cleared 510(K)
K
16
3564
SLIT LAMP SL-2000
2
Cleared 510(K)
K
16
2636
Marco Ultra M3, Marco Ultra M4
2
Cleared 510(K)
K
17
0171
IOLMaster 700
2
Cleared 510(K)
K
16
1607
VISULUX
2
Cleared 510(K)
K
16
1764
SLIT LAMP, Model: YF-100
2
Cleared 510(K)
K
16
1972
Slit Lamp SL-D301
2
Cleared 510(K)
K
16
0327
ALADDIN HW3.0
2
Cleared 510(K)
K
15
3545
Portable Slit Lamp
2
Cleared 510(K)
K
15
2535
Z5 Slit lamp microscope, Z2 Slit lamp microscope
2
Cleared 510(K)
K
15
2429
Slit Lamp Microscope
2
Cleared 510(K)
K
15
1394
Keeler Slit Lamp
2
Cleared 510(K)
K
14
3275
IOLMaster700
2
Cleared 510(K)
K
14
1954
XCEL 455 SLIT LAMP
2
Cleared 510(K)
K
14
1068
ZEISS CATARACT SUITE MARKERLESS
2
Cleared 510(K)
K
13
3667
SLIT LAMP SL-D701
2
Cleared 510(K)
K
14
0451
KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION)
2
Cleared 510(K)
K
13
3062
DISCOVERY SYSTEM
2
Cleared 510(K)
K
13
3132
OPTICAL BIOMETER AL-SCAN
2
Cleared 510(K)
K
13
1567
ALADDIN
2
Cleared 510(K)
K
13
1711
YZ3 PORTABLE SLIT LAMP
2
Cleared 510(K)
K
13
3755
KOWA SL-17
2
Cleared 510(K)
K
13
3476
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
2
Cleared 510(K)
K
13
1589
KEELER SLIT LAMP H-SERIES
2
Cleared 510(K)
K
12
2418
IOLMASTER 500
2
Cleared 510(K)
K
11
0129
RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
2
Cleared 510(K)
K
11
0489
SLIT LAMP SL-2G
2
Cleared 510(K)
K
10
1182
IOLMASTER 500
2
Cleared 510(K)
K
10
0439
MEDIWORKS SLIT LAMP
2
Cleared 510(K)
K
10
0202
SLIT LAMP BO 900, BQ 900, BP900
2
Cleared 510(K)
K
10
0500
PSL CLASSIC SLIT LAMP
2
Cleared 510(K)
K
09
3021
ATLANTIS SLIT LAMP
2
Cleared 510(K)
K
09
2883
LED LAMP OR OTHER
2
Cleared 510(K)
K
09
3639
SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
2
Cleared 510(K)
K
08
2891
LENSTAR, MODEL LS900
2
Cleared 510(K)
K
08
0776
GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72
2
Cleared 510(K)
K
08
2031
APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
2
Cleared 510(K)
K
07
2861
CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)
2
Cleared 510(K)
K
07
3190
SLIT LAMP
2
Cleared 510(K)
K
06
3352
ELLEX SLIT LAMP, MODEL 30XL
2
Cleared 510(K)
K
06
3750
XCEL 255 SLIT LAMP
2
Cleared 510(K)
K
06
3640
KOWA SL-15
2
Cleared 510(K)
K
06
3416
LUXVISION SLIT LAMP
2
Cleared 510(K)
K
06
1330
PSL PORTABLE SLIT LAMP
2
Cleared 510(K)
K
06
0869
RS-1000 ZOOM SLITLAMP WITH OPTION
2
Cleared 510(K)
K
04
3503
VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
2
Cleared 510(K)
K
03
3190
VISION-TECH YZ SLIT LAMP, MODEL 66
2
Cleared 510(K)
K
01
2873
DOCUMENTING LASER SLIT LAMP, DP 2010
2
Cleared 510(K)
K
01
2416
CONFOSCAN 2 CONFOCAL MICROSCOPE
2
Cleared 510(K)
K
99
3357
IOLMASTER
2
Cleared 510(K)
K
99
2836
SL990, SL980, SL950
2
Cleared 510(K)
K
98
2057
BC 900 SLIT LAMP
2
Cleared 510(K)
K
97
3064
KEELER TEARSCOPE-PLUS
2
Cleared 510(K)
K
97
4467
AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08
2
Cleared 510(K)
K
97
1953
CONFOSCAN
2
Cleared 510(K)
K
97
0414
CONFOCAL MICROSCOPE
2
Cleared 510(K)
K
96
2532
RODENSTOCK SLITLAMP (MODEL 5000 & 4000)
2
Cleared 510(K)
K
96
2522
MODEL SL-YZ5E
2
Cleared 510(K)
K
95
4782
KOWA PORTABLE SLIT LAMP SL-14 & SL-14B
2
Cleared 510(K)
K
94
5445
BOBES SLIT LAMP
2
Cleared 510(K)
K
95
3965
904 SLIT LAMP
2
Cleared 510(K)
K
95
3030
SLIT LAMP AIA 11
2
Cleared 510(K)
K
95
1341
NEITZ SLIT LAMP SL-H2
2
Cleared 510(K)
K
95
1184
OTI MODEL 78-60
2
Cleared 510(K)
K
95
1340
NEITZ SLIT LAMP SL-H1
2
Cleared 510(K)
K
95
1054
XCEL SLIT LAMP
2
Cleared 510(K)
K
94
4910
TOMEY EM-1000 SPECULAR MICROSCOPE
2
Cleared 510(K)
K
93
6209
SLIT LAMP, H-201
2
Cleared 510(K)
K
93
0518
TALIA LASER SLIT
2
Cleared 510(K)
K
92
5641
ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR
2
Cleared 510(K)
K
93
0438
MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS
2
Cleared 510(K)
K
92
4783
BURTON SLIT LAMP - MODEL 850
2
Cleared 510(K)
K
92
4782
BURTON SLIT LAMP - MODEL 2000
2
Cleared 510(K)
K
92
4787
BURTON SLIT LAMP
2
Cleared 510(K)
K
92
4770
BURTON HAND HELD SLIT LAMP - MODEL SL750
2
Cleared 510(K)
K
91
5356
OPACITRAC
2
Cleared 510(K)
K
91
3852
LASER FLARE METER
2
Cleared 510(K)
K
91
2514
TANDEM SCANNING MICROSCOPE
2
Cleared 510(K)
K
91
0980
SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
2
Cleared 510(K)
K
90
0477
WOODLYN CLASSIC SLIT LAMP MODEL SMM
2
Cleared 510(K)
K
90
0476
WOODLYN SLIT LAMP MODEL HR-1
2
Cleared 510(K)
K
88
0920
LASER FLARE CELL METER FC-1000
2
Cleared 510(K)
K
87
4160
ZEISS 40 SL/P PHOTO SLIT LAMP
2
Cleared 510(K)
K
87
4220
OCS 100 (OCULAR COMPARATOR SYSTEM)
2
Cleared 510(K)
K
86
3970
MLC ENDOTHELIAL CELL COUNTER
2
Cleared 510(K)
K
86
3048
OPM SLIT LAMP MODEL P-1 & MODEL P-3
2
Cleared 510(K)
K
86
2379
CORNEAL MODELING SYSTEM
2
Cleared 510(K)
K
86
2520
BAUSCH & LOMB PSL-3000 SLIT LAMP
2
Cleared 510(K)
K
86
2516
BAUSCH & LOMB OSL-2000 SLIT LAMP
2
Cleared 510(K)
K
86
2515
BAUSCH & LOMB CSL-1000 SLIT LAMP
2
Cleared 510(K)
K
86
1854
OPM SLIT LAMP MODEL P-1
2
Cleared 510(K)
K
86
2004
ZEISS 30 SL-L
2
Cleared 510(K)
K
84
2859
MICROSCOPE MITTS SUPPORT TRAY COVER
2
Cleared 510(K)
K
83
2911
ABBOTT GLOBE HOLDER
2
Cleared 510(K)
K
81
3313
BIOMICROSCOPY CONTACT LENS
2
Cleared 510(K)
K
81
1153
COHERENT FLOUROTRON MASTER
2
Cleared 510(K)
K
81
0403
KEELER/KONAN SPECULAR MICROSCOPE
2
Cleared 510(K)
K
80
2355
METRICON #120 FLUOROPHOTOMETER
2
Cleared 510(K)
K
80
1659
BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE
2
Cleared 510(K)
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 26 May 2023 at 11:04 pm
OP
/
diagnostic-devices
/
HJO
/
K161607
View Source
VISULUX
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161607
510(k) Type
Traditional
Applicant
CARL ZEISS MEDITEC AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
2/23/2017
Days to Decision
258 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
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
HJL
Lens, Condensing, Diagnostic
HJM
Transilluminator, Ac-Powered
HJN
Transilluminator, Battery-Powered
HJO
Biomicroscope, Slit-Lamp, Ac-Powered
K
19
3188
MiiS Horus Eye Anterior Camera
K
18
2306
Sunkingdom Slit Lamp
K
17
3771
IOLMaster 700
K
17
1877
SLM-1ER, SLM-2ER, SLM-3ER
K
17
0470
Digital Eye Anterior Camera
K
16
2778
Portable Slit Lamp Microscope
K
16
2684
SL 220
K
16
3564
SLIT LAMP SL-2000
K
16
2636
Marco Ultra M3, Marco Ultra M4
K
17
0171
IOLMaster 700
K
16
1607
VISULUX
K
16
1764
SLIT LAMP, Model: YF-100
K
16
1972
Slit Lamp SL-D301
K
16
0327
ALADDIN HW3.0
K
15
3545
Portable Slit Lamp
K
15
2535
Z5 Slit lamp microscope, Z2 Slit lamp microscope
K
15
2429
Slit Lamp Microscope
K
15
1394
Keeler Slit Lamp
K
14
3275
IOLMaster700
K
14
1954
XCEL 455 SLIT LAMP
K
14
1068
ZEISS CATARACT SUITE MARKERLESS
K
13
3667
SLIT LAMP SL-D701
K
14
0451
KEELER SLIT LAMP H-SERIES DIGITAL (HALOGEN BULB OPTION), KEELER SLIT LAMP H-SERIES DIGITAL (LED OPTION)
K
13
3062
DISCOVERY SYSTEM
K
13
3132
OPTICAL BIOMETER AL-SCAN
K
13
1567
ALADDIN
K
13
1711
YZ3 PORTABLE SLIT LAMP
K
13
3755
KOWA SL-17
K
13
3476
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
K
13
1589
KEELER SLIT LAMP H-SERIES
K
12
2418
IOLMASTER 500
K
11
0129
RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
K
11
0489
SLIT LAMP SL-2G
K
10
1182
IOLMASTER 500
K
10
0439
MEDIWORKS SLIT LAMP
K
10
0202
SLIT LAMP BO 900, BQ 900, BP900
K
10
0500
PSL CLASSIC SLIT LAMP
K
09
3021
ATLANTIS SLIT LAMP
K
09
2883
LED LAMP OR OTHER
K
09
3639
SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
K
08
2891
LENSTAR, MODEL LS900
K
08
0776
GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72
K
08
2031
APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES
K
07
2861
CEEMAX SLIT LAMP (HALOGEN LAMP SERIES/SOLID STATE ILLUMINATION SERIES)
K
07
3190
SLIT LAMP
K
06
3352
ELLEX SLIT LAMP, MODEL 30XL
K
06
3750
XCEL 255 SLIT LAMP
K
06
3640
KOWA SL-15
K
06
3416
LUXVISION SLIT LAMP
K
06
1330
PSL PORTABLE SLIT LAMP
K
06
0869
RS-1000 ZOOM SLITLAMP WITH OPTION
K
04
3503
VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1
K
03
3190
VISION-TECH YZ SLIT LAMP, MODEL 66
K
01
2873
DOCUMENTING LASER SLIT LAMP, DP 2010
K
01
2416
CONFOSCAN 2 CONFOCAL MICROSCOPE
K
99
3357
IOLMASTER
K
99
2836
SL990, SL980, SL950
K
98
2057
BC 900 SLIT LAMP
K
97
3064
KEELER TEARSCOPE-PLUS
K
97
4467
AESCULAP-MEDITEC SLIT LAMPS SL07 AND SL08
K
97
1953
CONFOSCAN
K
97
0414
CONFOCAL MICROSCOPE
K
96
2532
RODENSTOCK SLITLAMP (MODEL 5000 & 4000)
K
96
2522
MODEL SL-YZ5E
K
95
4782
KOWA PORTABLE SLIT LAMP SL-14 & SL-14B
K
94
5445
BOBES SLIT LAMP
K
95
3965
904 SLIT LAMP
K
95
3030
SLIT LAMP AIA 11
K
95
1341
NEITZ SLIT LAMP SL-H2
K
95
1184
OTI MODEL 78-60
K
95
1340
NEITZ SLIT LAMP SL-H1
K
95
1054
XCEL SLIT LAMP
K
94
4910
TOMEY EM-1000 SPECULAR MICROSCOPE
K
93
6209
SLIT LAMP, H-201
K
93
0518
TALIA LASER SLIT
K
92
5641
ZEISS 20 SL SLIT-LAMP & MECHANICAL MICROMANIPULATR
K
93
0438
MARCO MODELS G,H AND PRIMARY CARE SLIT LAMPS
K
92
4783
BURTON SLIT LAMP - MODEL 850
K
92
4782
BURTON SLIT LAMP - MODEL 2000
K
92
4787
BURTON SLIT LAMP
K
92
4770
BURTON HAND HELD SLIT LAMP - MODEL SL750
K
91
5356
OPACITRAC
K
91
3852
LASER FLARE METER
K
91
2514
TANDEM SCANNING MICROSCOPE
K
91
0980
SITE 20 GAUGE REUSABLE FIBER OPTIC CABLE
K
90
0477
WOODLYN CLASSIC SLIT LAMP MODEL SMM
K
90
0476
WOODLYN SLIT LAMP MODEL HR-1
K
88
0920
LASER FLARE CELL METER FC-1000
K
87
4160
ZEISS 40 SL/P PHOTO SLIT LAMP
K
87
4220
OCS 100 (OCULAR COMPARATOR SYSTEM)
K
86
3970
MLC ENDOTHELIAL CELL COUNTER
K
86
3048
OPM SLIT LAMP MODEL P-1 & MODEL P-3
K
86
2379
CORNEAL MODELING SYSTEM
K
86
2520
BAUSCH & LOMB PSL-3000 SLIT LAMP
K
86
2516
BAUSCH & LOMB OSL-2000 SLIT LAMP
K
86
2515
BAUSCH & LOMB CSL-1000 SLIT LAMP
K
86
1854
OPM SLIT LAMP MODEL P-1
K
86
2004
ZEISS 30 SL-L
K
84
2859
MICROSCOPE MITTS SUPPORT TRAY COVER
K
83
2911
ABBOTT GLOBE HOLDER
K
81
3313
BIOMICROSCOPY CONTACT LENS
K
81
1153
COHERENT FLOUROTRON MASTER
K
81
0403
KEELER/KONAN SPECULAR MICROSCOPE
K
80
2355
METRICON #120 FLUOROPHOTOMETER
K
80
1659
BIOPHTAL CLINICAL ENDOTHELIAL MICROSCOPE
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
/
HJO
/
K161607
View Source
VISULUX
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K161607
510(k) Type
Traditional
Applicant
CARL ZEISS MEDITEC AG
Country
Germany
FDA Decision
Substantially Equivalent
Decision Date
2/23/2017
Days to Decision
258 days
Submission Type
Summary