Device Classification Name |
Light Based Over-The-Counter Hair Removal
|
510(k) Number |
K190366 |
Device Name |
BRAUN Silk Expert Pro 3 |
Applicant |
CyDen Limited |
Block A, Bay Studios Business Park, Fabian Way |
Swansea,
GB
SA1 8QB
|
|
Applicant Contact |
Adam Stephens |
Correspondent |
CyDen Limited |
Block A, Bay Studios Business Park, Fabian Way |
Swansea,
GB
SA1 8QB
|
|
Correspondent Contact |
Adam Stephens |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/15/2019 |
Decision Date | 03/18/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|