Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K142824 |
Device Name |
LX-100 Hair Growth Stimulation System |
Applicant |
Hairlabs International Inc |
742 Harpeth Knoll Road |
Nashville,
TN
37221
|
|
Applicant Contact |
James Britt |
Correspondent |
Hairlabs International Inc |
742 Harpeth Knoll Road |
Nashville,
TN
37221
|
|
Correspondent Contact |
James Britt |
Regulation Number | 890.5500 |
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/30/2014 |
Decision Date | 04/14/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|