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FDA Browser
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Innolitics
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Review Panel
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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
K
21
3027
Laser Hair Growth Comb
2
Cleared 510(K)
K
21
3025
Laser hair growth helmet
2
Cleared 510(K)
K
22
0543
Auxo A300, A150 and APod
2
Cleared 510(K)
K
21
3447
LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
2
Cleared 510(K)
K
21
3094
ID-500 iRestore Hair Growth System
2
Cleared 510(K)
K
21
1192
Grivamax Family of Lasers, Models 272 and 148
2
Cleared 510(K)
K
21
1038
Biophotas Celluma RESTORE
2
Cleared 510(K)
K
21
0169
Hair Growth Device
2
Cleared 510(K)
K
20
3826
LaserCap Family of Lasers 300, 224, 120 & 80
2
Cleared 510(K)
K
20
2983
easy Hairfull
2
Cleared 510(K)
Show All 77 Submissions
OZC
Over The Counter Thermal Treatment For Acne.
2
Product Code
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 26 May 2023 at 11:04 pm
SU
/
physical-medicine-therapeutic-devices
/
OAP
/
K213025
View Source
Laser hair growth helmet
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213025
510(k) Type
Traditional
Applicant
Kam Yuen Plastic Products Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
5/12/2022
Days to Decision
233 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
K
21
3027
Laser Hair Growth Comb
K
21
3025
Laser hair growth helmet
K
22
0543
Auxo A300, A150 and APod
K
21
3447
LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
K
21
3094
ID-500 iRestore Hair Growth System
K
21
1192
Grivamax Family of Lasers, Models 272 and 148
K
21
1038
Biophotas Celluma RESTORE
K
21
0169
Hair Growth Device
K
20
3826
LaserCap Family of Lasers 300, 224, 120 & 80
K
20
2983
easy Hairfull
Show All 77 Submissions
OZC
Over The Counter Thermal Treatment For Acne.
Prosthetic Devices
Surgical Devices
Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
physical-medicine-therapeutic-devices
/
OAP
/
K213025
View Source
Laser hair growth helmet
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213025
510(k) Type
Traditional
Applicant
Kam Yuen Plastic Products Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
5/12/2022
Days to Decision
233 days
Submission Type
Summary