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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
NZY
Light, Lymphedema Reduction, Low Energy
2
Product Code
OAP
Laser, Comb, Hair
2
Product Code
OZC
Over The Counter Thermal Treatment For Acne.
2
Product Code
K
11
1341
CLEANE / CLEANE POP
2
Cleared 510(K)
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 31 March 2023 at 11:04 pm
SU
/
physical-medicine-therapeutic-devices
/
OZC
/
K111341
View Source
CLEANE / CLEANE POP
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111341
510(k) Type
Traditional
Applicant
MEDICON CO., LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/29/2012
Days to Decision
293 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
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
NZY
Light, Lymphedema Reduction, Low Energy
OAP
Laser, Comb, Hair
OZC
Over The Counter Thermal Treatment For Acne.
K
11
1341
CLEANE / CLEANE POP
Prosthetic Devices
Surgical Devices
Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
physical-medicine-therapeutic-devices
/
OZC
/
K111341
View Source
CLEANE / CLEANE POP
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K111341
510(k) Type
Traditional
Applicant
MEDICON CO., LTD.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
2/29/2012
Days to Decision
293 days
Submission Type
Summary