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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
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
K
14
2486
HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
2
Cleared 510(K)
K
14
2837
HEINE SIGMA 250 & HEINE SIGMA 250 M2
2
Cleared 510(K)
K
13
1959
HEINE MINI 3000(R) OPHTHALMOSCOPE
2
Cleared 510(K)
K
13
1961
HEINE BETA 200(R) OPHTHALMOSCOPE
2
Cleared 510(K)
K
13
1719
OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
2
Cleared 510(K)
K
12
3587
HEINE MINI 3000 LED OPHTHALMOSCOPE
2
Cleared 510(K)
K
09
3495
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
2
Cleared 510(K)
K
07
0270
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
2
Cleared 510(K)
K
05
2599
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
2
Cleared 510(K)
K
06
1278
OPTYSE OPHTHALMOSCOPE
2
Cleared 510(K)
K
05
3425
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
2
Cleared 510(K)
K
03
2087
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
2
Cleared 510(K)
K
00
2044
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
2
Cleared 510(K)
K
96
2767
MS401097-17,MS722-K,MS720,MS721,MS722
2
Cleared 510(K)
K
97
0029
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
2
Cleared 510(K)
K
95
0914
RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V
2
Cleared 510(K)
K
95
0797
HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134
2
Cleared 510(K)
K
95
0796
HALOGEN DIAGNOSTIC SET BX A - 12345
2
Cleared 510(K)
K
94
5640
RI-SCOPE S OTOSCOPE
2
Cleared 510(K)
K
94
4402
FOCOMETER
2
Cleared 510(K)
K
94
2721
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13
2
Cleared 510(K)
K
94
2719
NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR
2
Cleared 510(K)
K
94
2717
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A
2
Cleared 510(K)
K
94
2034
R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502
2
Cleared 510(K)
K
93
6104
R & D BATTERIES
2
Cleared 510(K)
K
93
6018
REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
2
Cleared 510(K)
K
92
5755
DE LUXE
2
Cleared 510(K)
K
92
5756
UNI II
2
Cleared 510(K)
K
93
2504
RI-FORMER
2
Cleared 510(K)
K
92
5757
OPHTHALMOSCOPE
2
Cleared 510(K)
K
92
3543
MIS
2
Cleared 510(K)
K
92
2910
MEDICAL BATTERY PACKS
2
Cleared 510(K)
K
92
0272
ORIEL
2
Cleared 510(K)
K
89
6072
D.L. SCOPE OPHTHALMOSCOPE
2
Cleared 510(K)
K
87
3987
IRAS GLARE TESTER
2
Cleared 510(K)
K
87
1735
VOROSCOPE(TM)
2
Cleared 510(K)
K
85
3891
INDIRECT OPHTHALMOSCOPE
2
Cleared 510(K)
K
85
2953
#SM-3001 OPHTHA OTOSC SET SUBSETS SOLD
2
Cleared 510(K)
K
85
2334
MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)
2
Cleared 510(K)
K
84
3897
POCKET OPHTHALMOSCOPE GH
2
Cleared 510(K)
K
84
2567
PORTABLE ACUIOMETER
2
Cleared 510(K)
K
84
1292
SPECTACLE INDIRECT OPHTHALMOSCOPE
2
Cleared 510(K)
K
83
2437
MEDIC LUX DIAGNOSTIC SETS
2
Cleared 510(K)
K
83
0215
DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
2
Cleared 510(K)
K
78
0215
EYESCOPE
2
Cleared 510(K)
K
76
0771
SOLA SCHULTZE-CROCK OPTHALMOSCOPE
2
Cleared 510(K)
K
76
0770
SOLA COMMIDO LOUPE
2
Cleared 510(K)
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 9 June 2023 at 11:04 pm
OP
/
diagnostic-devices
/
HLJ
/
K760770
View Source
SOLA COMMIDO LOUPE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K760770
510(k) Type
Traditional
Applicant
Codman & Shurtleff, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/15/1976
Days to Decision
11 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
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
K
14
2486
HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
K
14
2837
HEINE SIGMA 250 & HEINE SIGMA 250 M2
K
13
1959
HEINE MINI 3000(R) OPHTHALMOSCOPE
K
13
1961
HEINE BETA 200(R) OPHTHALMOSCOPE
K
13
1719
OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
K
12
3587
HEINE MINI 3000 LED OPHTHALMOSCOPE
K
09
3495
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
K
07
0270
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
K
05
2599
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
K
06
1278
OPTYSE OPHTHALMOSCOPE
K
05
3425
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
K
03
2087
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
K
00
2044
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
K
96
2767
MS401097-17,MS722-K,MS720,MS721,MS722
K
97
0029
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
K
95
0914
RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V
K
95
0797
HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134
K
95
0796
HALOGEN DIAGNOSTIC SET BX A - 12345
K
94
5640
RI-SCOPE S OTOSCOPE
K
94
4402
FOCOMETER
K
94
2721
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13
K
94
2719
NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR
K
94
2717
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A
K
94
2034
R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502
K
93
6104
R & D BATTERIES
K
93
6018
REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
K
92
5755
DE LUXE
K
92
5756
UNI II
K
93
2504
RI-FORMER
K
92
5757
OPHTHALMOSCOPE
K
92
3543
MIS
K
92
2910
MEDICAL BATTERY PACKS
K
92
0272
ORIEL
K
89
6072
D.L. SCOPE OPHTHALMOSCOPE
K
87
3987
IRAS GLARE TESTER
K
87
1735
VOROSCOPE(TM)
K
85
3891
INDIRECT OPHTHALMOSCOPE
K
85
2953
#SM-3001 OPHTHA OTOSC SET SUBSETS SOLD
K
85
2334
MODEL BX OPHTHALMOSCOPE(BX-RP INCLUDES BATTE HAN)
K
84
3897
POCKET OPHTHALMOSCOPE GH
K
84
2567
PORTABLE ACUIOMETER
K
84
1292
SPECTACLE INDIRECT OPHTHALMOSCOPE
K
83
2437
MEDIC LUX DIAGNOSTIC SETS
K
83
0215
DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
K
78
0215
EYESCOPE
K
76
0771
SOLA SCHULTZE-CROCK OPTHALMOSCOPE
K
76
0770
SOLA COMMIDO LOUPE
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
/
HLJ
/
K760770
View Source
SOLA COMMIDO LOUPE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K760770
510(k) Type
Traditional
Applicant
Codman & Shurtleff, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/15/1976
Days to Decision
11 days