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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
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Diagnostic Devices
CFR Sub-Part
General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Miscellaneous
Miscellaneous
Neurological Surgical Devices
CFR Sub-Part
Physical Medicine Therapeutic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
NGU
Balloon, Liver Tamponade
2
Product Code
EYR
Tourniquet, Gastro-Urology
1
Product Code
EXM
Truss, Umbilical
1
Product Code
EYN
Tray, Irrigation, Sterile
2
Product Code
FBQ
Trocar, Gastro-Urology
2
Product Code
FZG
Apparatus, Air Handling, Bench
2
Product Code
FZH
Apparatus, Air Handling, Room
2
Product Code
FZI
Apparatus, Air Handling, Enclosure
2
Product Code
GAX
Tourniquet, Nonpneumatic
1
Product Code
KCW
Epilator, High Frequency, Needle-Type
1
Product Code
K
95
4031
COMPU-BLEND EPILATOR
1
Cleared 510(K)
K
95
2611
STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION
1
Cleared 510(K)
K
94
5192
HAIR REMOVAL SYSTEM
1
Cleared 510(K)
K
94
3928
APILUS ELECTROPIL
1
Cleared 510(K)
K
94
3398
THE BLENDTONE ROYALE
1
Cleared 510(K)
K
94
3399
THE SS-99
1
Cleared 510(K)
K
94
3396
THE ELITE SPECTRUM
1
Cleared 510(K)
K
94
1227
SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL
1
Cleared 510(K)
K
93
1063
THE ELITE EPILATOR
1
Cleared 510(K)
K
93
1062
THE VP500 EPILATOR
1
Cleared 510(K)
K
93
1064
THE BLENDTONE EPILATOR
1
Cleared 510(K)
K
91
1983
WIZARD STERILIZED ELECTROEPILATION NEEDLE
1
Cleared 510(K)
K
90
4015
ELECTRO-BLEND EPILATOR, MODEL UC-3
1
Cleared 510(K)
K
89
5687
D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE)
1
Cleared 510(K)
K
89
4771
EPILATION NEEDLE
1
Cleared 510(K)
K
89
3389
MODEL SE-5 EPILATOR
1
Cleared 510(K)
K
88
3892
BALLET STERILE DISPOSABLE ELECTROLYSIS
1
Cleared 510(K)
K
88
4079
MODEL CBX EPILATOR
1
Cleared 510(K)
K
88
3429
LINDSTROM CORDLESS EPILATOR
1
Cleared 510(K)
K
88
1276
HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS
1
Cleared 510(K)
K
88
0553
ELECTRONIC EPILATOR
1
Cleared 510(K)
K
87
4891
FLEXIE THE COPPER SHANK NEEDLE
1
Cleared 510(K)
K
86
4869
HR-5000 ELECTROSURGICAL DEVICE
1
Cleared 510(K)
K
87
1372
CB-7 ELECTRONIC EPILATOR
1
Cleared 510(K)
K
86
4291
HIGH FREQUENCY NEEDLE-TYPE EPILATOR
1
Cleared 510(K)
K
86
4289
MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR
1
Cleared 510(K)
K
86
0056
BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR)
1
Cleared 510(K)
K
85
1318
GUIBOR MICROELECTROLYSIS UNIT 18
1
Cleared 510(K)
K
84
3063
ELECTRONIC EPILATOR TS-1
1
Cleared 510(K)
K
83
4572
EPITRON SUPER
1
Cleared 510(K)
K
83
3946
EPILOT 80 S TM
1
Cleared 510(K)
K
83
1048
TUFCOTE EPILATION PROBE
1
Cleared 510(K)
K
82
3674
HIGH FREQUENCY EPILATOR CB-2
1
Cleared 510(K)
K
82
0650
LPS 1118
1
Cleared 510(K)
K
81
3637
STOLTRONICS-LRS
1
Cleared 510(K)
K
81
1503
EPILATOR, BLEND-MODEL EB-200 & ET-1
1
Cleared 510(K)
K
81
1501
EPILATOR, MULTIPLE NEEDLE-MODEL EM-20
1
Cleared 510(K)
K
81
0843
EPILATRON
1
Cleared 510(K)
K
80
1555
COMPACT MODEL 360 GALVANIC EPILATOR
1
Cleared 510(K)
K
80
1351
EPILATOR, MODEL CP-16
1
Cleared 510(K)
K
78
1147
EPILATOR, EASE-MULTI-MODE
1
Cleared 510(K)
K
78
0337
THERMOLYSIS GENERATOR
1
Cleared 510(K)
K
78
0076
EPILATOR, ELECTRONIC MODEL SE-2
1
Cleared 510(K)
KCX
Epilator, High Frequency, Tweezer-Type
1
Product Code
KCY
Tourniquet, Pneumatic
1
Product Code
KPJ
Chamber, Oxygen, Topical, Extremity
2
Product Code
OJS
Tourniquet Kit
1
Product Code
OLI
Fat Reducing Low Level Laser
2
Product Code
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
2
Product Code
QGX
General Use Pneumatic Tourniquet
1
Product Code
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 2 June 2023 at 11:04 pm
SU
/
therapeutic-devices
/
KCW
/
K864869
View Source
HR-5000 ELECTROSURGICAL DEVICE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K864869
510(k) Type
Traditional
Applicant
IME CO. LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/19/1987
Days to Decision
158 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
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Diagnostic Devices
General Hospital and Personal Use Monitoring Devices
General Hospital and Personal Use Therapeutic Devices
Miscellaneous
Neurological Surgical Devices
Physical Medicine Therapeutic Devices
Prosthetic Devices
Surgical Devices
Therapeutic Devices
NGU
Balloon, Liver Tamponade
EYR
Tourniquet, Gastro-Urology
EXM
Truss, Umbilical
EYN
Tray, Irrigation, Sterile
FBQ
Trocar, Gastro-Urology
FZG
Apparatus, Air Handling, Bench
FZH
Apparatus, Air Handling, Room
FZI
Apparatus, Air Handling, Enclosure
GAX
Tourniquet, Nonpneumatic
KCW
Epilator, High Frequency, Needle-Type
K
95
4031
COMPU-BLEND EPILATOR
K
95
2611
STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION
K
94
5192
HAIR REMOVAL SYSTEM
K
94
3928
APILUS ELECTROPIL
K
94
3398
THE BLENDTONE ROYALE
K
94
3399
THE SS-99
K
94
3396
THE ELITE SPECTRUM
K
94
1227
SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL
K
93
1063
THE ELITE EPILATOR
K
93
1062
THE VP500 EPILATOR
K
93
1064
THE BLENDTONE EPILATOR
K
91
1983
WIZARD STERILIZED ELECTROEPILATION NEEDLE
K
90
4015
ELECTRO-BLEND EPILATOR, MODEL UC-3
K
89
5687
D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE)
K
89
4771
EPILATION NEEDLE
K
89
3389
MODEL SE-5 EPILATOR
K
88
3892
BALLET STERILE DISPOSABLE ELECTROLYSIS
K
88
4079
MODEL CBX EPILATOR
K
88
3429
LINDSTROM CORDLESS EPILATOR
K
88
1276
HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS
K
88
0553
ELECTRONIC EPILATOR
K
87
4891
FLEXIE THE COPPER SHANK NEEDLE
K
86
4869
HR-5000 ELECTROSURGICAL DEVICE
K
87
1372
CB-7 ELECTRONIC EPILATOR
K
86
4291
HIGH FREQUENCY NEEDLE-TYPE EPILATOR
K
86
4289
MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR
K
86
0056
BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR)
K
85
1318
GUIBOR MICROELECTROLYSIS UNIT 18
K
84
3063
ELECTRONIC EPILATOR TS-1
K
83
4572
EPITRON SUPER
K
83
3946
EPILOT 80 S TM
K
83
1048
TUFCOTE EPILATION PROBE
K
82
3674
HIGH FREQUENCY EPILATOR CB-2
K
82
0650
LPS 1118
K
81
3637
STOLTRONICS-LRS
K
81
1503
EPILATOR, BLEND-MODEL EB-200 & ET-1
K
81
1501
EPILATOR, MULTIPLE NEEDLE-MODEL EM-20
K
81
0843
EPILATRON
K
80
1555
COMPACT MODEL 360 GALVANIC EPILATOR
K
80
1351
EPILATOR, MODEL CP-16
K
78
1147
EPILATOR, EASE-MULTI-MODE
K
78
0337
THERMOLYSIS GENERATOR
K
78
0076
EPILATOR, ELECTRONIC MODEL SE-2
KCX
Epilator, High Frequency, Tweezer-Type
KCY
Tourniquet, Pneumatic
KPJ
Chamber, Oxygen, Topical, Extremity
OJS
Tourniquet Kit
OLI
Fat Reducing Low Level Laser
PKT
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
QGX
General Use Pneumatic Tourniquet
Toxicology
Medical Genetics
Unknown
SU
/
therapeutic-devices
/
KCW
/
K864869
View Source
HR-5000 ELECTROSURGICAL DEVICE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K864869
510(k) Type
Traditional
Applicant
IME CO. LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
5/19/1987
Days to Decision
158 days