Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K160728 |
Device Name |
NutraStim Hair Laser Helmet |
Applicant |
NUTRA LUXE MD LLC |
12801 COMMONWEALTH DR. UNIT 2-6 |
FORT MYERS,
FL
33976
|
|
Applicant Contact |
GLORIA AVENDANO |
Correspondent |
NUTRA LUXE MD LLC |
12801 COMMONWEALTH DR. UNIT 2-6 |
FORT MYERS,
FL
33976
|
|
Correspondent Contact |
GLORIA AVENDANO |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 03/16/2016 |
Decision Date | 09/16/2016 |
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
|
|
|