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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
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
HKX
Tonometer, Ac-Powered
2
Product Code
K
19
0382
Intraocular Pressure Tonometer EASYTON
2
Cleared 510(K)
K
18
1260
MiiS Horus Scope DPT 100
2
Cleared 510(K)
K
18
1143
Keeler TonoCare Tonometer
2
Cleared 510(K)
K
18
0820
Tono Vue Non-Contact Tonometer
2
Cleared 510(K)
K
16
2067
VX130 Ophthalmic Diagnostic Device
2
Cleared 510(K)
K
14
3086
VX120 Ophthalmic Diagnostic Device
2
Cleared 510(K)
K
11
3066
CORVIS ST
2
Cleared 510(K)
K
11
1710
FULL AUTO TONOMETER MODEL TX-20
2
Cleared 510(K)
K
09
3298
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
2
Cleared 510(K)
K
08
3377
ACCUPEN
2
Cleared 510(K)
K
07
3087
NON-CONTACT TONOMETER, MODEL FT-1000
2
Cleared 510(K)
K
08
1756
OCULAR RESPONSE ANALYZER
2
Cleared 510(K)
K
05
3444
KOWA KT-800
2
Cleared 510(K)
K
06
0780
TONOMETER DIATON
2
Cleared 510(K)
K
04
2099
TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)
2
Cleared 510(K)
K
03
2799
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
2
Cleared 510(K)
K
03
1733
NON-CONTACT TONOMETER, MODEL NT-4000
2
Cleared 510(K)
K
02
3676
APPLANATION TONOMETER
2
Cleared 510(K)
K
02
3816
CANON FULL AUTO TONOMETER TX-F
2
Cleared 510(K)
K
02
1937
TGDC-01 PRA
2
Cleared 510(K)
K
01
3805
KOWA AUTOMATED TONOMETER KT-500
2
Cleared 510(K)
K
01
3259
PORTABLE NON-CONTACT TONOMETER, MODEL PT100
2
Cleared 510(K)
K
01
0998
LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
2
Cleared 510(K)
K
00
2395
MODEL 30 CLASSIC PNEUMATONOMETER
2
Cleared 510(K)
K
00
2510
SMARTLENS
2
Cleared 510(K)
K
99
0869
LEICA AT550
2
Cleared 510(K)
K
99
0257
KEELER PULSAIR 3000 NON CONTACT TONOMETER
2
Cleared 510(K)
K
96
3079
CANON TX-10 TONOMETER
2
Cleared 510(K)
K
95
3031
ZEIMER SELF TONOMETER
2
Cleared 510(K)
K
94
5972
DIGITAL AVERAGING TONOMETER
2
Cleared 510(K)
K
94
3939
NON-CONTACT TONOMETER T-2
2
Cleared 510(K)
K
94
1865
XPERT NCT
2
Cleared 510(K)
K
92
1443
TIP & MEMBRANE ASSEMBLY
2
Cleared 510(K)
K
92
4777
BURTON APPLANATION TONOMETER - MODEL T850 & T1000
2
Cleared 510(K)
K
92
1617
CYLINDER OF GAS, CAN OF GAS (CC12F2)
2
Cleared 510(K)
K
91
3189
NIDEK MODEL NT-1000
2
Cleared 510(K)
K
91
1721
KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION
2
Cleared 510(K)
K
89
5575
BIO-RAD MODULAR AIR COMPRESSOR
2
Cleared 510(K)
K
88
4012
MMAC II TONOMETER
2
Cleared 510(K)
K
87
3917
TONOMETER TAPES
2
Cleared 510(K)
K
87
3422
OBF MODEL 115 COMPUTER TONOMETER SYSTEM
2
Cleared 510(K)
K
87
1935
T P C (TONOMETER PROBE COVER)
2
Cleared 510(K)
K
87
1335
TOPCON COMPUTERIZED TONOMETER CT-10
2
Cleared 510(K)
K
87
0750
KEELER PULSAIR NON CONTACT TONOMETER
2
Cleared 510(K)
K
87
0121
DIGILAB MICRO ONE APPLANATION TONOMETER
2
Cleared 510(K)
K
86
4959
OBF MODEL 112 VACUUM CUP SYSTEM
2
Cleared 510(K)
K
86
3235
SURGICAL IOP MONITOR
2
Cleared 510(K)
K
86
3217
DIGILAB MODULAR ONE-APPLANATION TONOMETER
2
Cleared 510(K)
K
86
3200
COMPUTON(R)
2
Cleared 510(K)
K
84
3354
EPISCLERAL VENOUS PRESSURE
2
Cleared 510(K)
K
84
1762
WOODLYN APPLANATION TONOMETER
2
Cleared 510(K)
K
84
0836
CAT 100
2
Cleared 510(K)
K
83
3494
CLERZ LUBRICATING/REWETTING SOLUTION
2
Cleared 510(K)
K
82
0751
GLAUKON
2
Cleared 510(K)
K
80
2419
AO NON-CONTACT II TONOMETER
2
Cleared 510(K)
K
80
1518
SPAN-AID BRIDGING PILLOW SYSTEM
2
Cleared 510(K)
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
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
QTO
Digital Visual Acuity Test
1
Product Code
QTW
Digital Amsler Grid
1
Product Code
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
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 22 September 2023 at 11:04 pm
OP
/
subpart-b—diagnostic-devices
/
HKX
/
K833494
View Source
CLERZ LUBRICATING/REWETTING SOLUTION
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K833494
510(k) Type
Traditional
Applicant
COOPERVISION, INC.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
1/4/1984
Days to Decision
89 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
Miscellaneous
Subpart B—Diagnostic Devices
HKX
Tonometer, Ac-Powered
K
19
0382
Intraocular Pressure Tonometer EASYTON
K
18
1260
MiiS Horus Scope DPT 100
K
18
1143
Keeler TonoCare Tonometer
K
18
0820
Tono Vue Non-Contact Tonometer
K
16
2067
VX130 Ophthalmic Diagnostic Device
K
14
3086
VX120 Ophthalmic Diagnostic Device
K
11
3066
CORVIS ST
K
11
1710
FULL AUTO TONOMETER MODEL TX-20
K
09
3298
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
K
08
3377
ACCUPEN
K
07
3087
NON-CONTACT TONOMETER, MODEL FT-1000
K
08
1756
OCULAR RESPONSE ANALYZER
K
05
3444
KOWA KT-800
K
06
0780
TONOMETER DIATON
K
04
2099
TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)
K
03
2799
NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER
K
03
1733
NON-CONTACT TONOMETER, MODEL NT-4000
K
02
3676
APPLANATION TONOMETER
K
02
3816
CANON FULL AUTO TONOMETER TX-F
K
02
1937
TGDC-01 PRA
K
01
3805
KOWA AUTOMATED TONOMETER KT-500
K
01
3259
PORTABLE NON-CONTACT TONOMETER, MODEL PT100
K
01
0998
LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 201
K
00
2395
MODEL 30 CLASSIC PNEUMATONOMETER
K
00
2510
SMARTLENS
K
99
0869
LEICA AT550
K
99
0257
KEELER PULSAIR 3000 NON CONTACT TONOMETER
K
96
3079
CANON TX-10 TONOMETER
K
95
3031
ZEIMER SELF TONOMETER
K
94
5972
DIGITAL AVERAGING TONOMETER
K
94
3939
NON-CONTACT TONOMETER T-2
K
94
1865
XPERT NCT
K
92
1443
TIP & MEMBRANE ASSEMBLY
K
92
4777
BURTON APPLANATION TONOMETER - MODEL T850 & T1000
K
92
1617
CYLINDER OF GAS, CAN OF GAS (CC12F2)
K
91
3189
NIDEK MODEL NT-1000
K
91
1721
KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION
K
89
5575
BIO-RAD MODULAR AIR COMPRESSOR
K
88
4012
MMAC II TONOMETER
K
87
3917
TONOMETER TAPES
K
87
3422
OBF MODEL 115 COMPUTER TONOMETER SYSTEM
K
87
1935
T P C (TONOMETER PROBE COVER)
K
87
1335
TOPCON COMPUTERIZED TONOMETER CT-10
K
87
0750
KEELER PULSAIR NON CONTACT TONOMETER
K
87
0121
DIGILAB MICRO ONE APPLANATION TONOMETER
K
86
4959
OBF MODEL 112 VACUUM CUP SYSTEM
K
86
3235
SURGICAL IOP MONITOR
K
86
3217
DIGILAB MODULAR ONE-APPLANATION TONOMETER
K
86
3200
COMPUTON(R)
K
84
3354
EPISCLERAL VENOUS PRESSURE
K
84
1762
WOODLYN APPLANATION TONOMETER
K
84
0836
CAT 100
K
83
3494
CLERZ LUBRICATING/REWETTING SOLUTION
K
82
0751
GLAUKON
K
80
2419
AO NON-CONTACT II TONOMETER
K
80
1518
SPAN-AID BRIDGING PILLOW SYSTEM
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
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
QTO
Digital Visual Acuity Test
QTW
Digital Amsler Grid
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
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
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subpart-b—diagnostic-devices
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HKX
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K833494
View Source
CLERZ LUBRICATING/REWETTING SOLUTION
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K833494
510(k) Type
Traditional
Applicant
COOPERVISION, INC.
Country
United Kingdom
FDA Decision
Substantially Equivalent
Decision Date
1/4/1984
Days to Decision
89 days