Device Classification Name |
light based over-the-counter hair removal
|
510(k) Number |
K143003 |
Device Name |
iPulse Smooth Skin Gold Hair Removal System |
Applicant |
Ipulse Limited |
Technium 2, Kings Road, The Docks |
Swansea,
GB
Sa1 8pJ
|
|
Applicant Contact |
Mike Kiernan |
Correspondent |
Ipulse Limited |
Technium 2, Kings Road, The Docks |
Swansea,
GB
Sa1 8pJ
|
|
Correspondent Contact |
Mike Kiernan |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/20/2014 |
Decision Date | 06/18/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|