Device Classification Name |
light based over-the-counter hair removal
|
510(k) Number |
K131870 |
Device Name |
GLIDE DEVICE |
Applicant |
HOME SKINOVATIONS LTD. |
20 HATA'AS STR., STE 102 |
KFAR SABA,
IL
44425
|
|
Applicant Contact |
AHAVA STEIN |
Correspondent |
HOME SKINOVATIONS LTD. |
20 HATA'AS STR., STE 102 |
KFAR SABA,
IL
44425
|
|
Correspondent Contact |
AHAVA STEIN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 06/24/2013 |
Decision Date | 08/14/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|