Device Classification Name |
Stimulator, Muscle, Powered, For Muscle Conditioning
|
510(k) Number |
K180279 |
Device Name |
Silk'n MODEL H5003 device |
Applicant |
Home Skinovations Ltd. |
Tabor Building, Shaar Yokneam |
Yoqneam Illit,
IL
2069200
|
|
Applicant Contact |
Amit Goren |
Correspondent |
A. Stein - Regulatory Affairs Consulting Ltd. |
20 Hata'as Str. |
Suite 102 |
Kfar Saba,
IL
4442520
|
|
Correspondent Contact |
Amit Goren |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 01/31/2018 |
Decision Date | 05/09/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|