Device Classification Name |
massager, vacuum, radio frequency induced heat
|
510(k) Number |
K153568 |
Device Name |
InMode Plus System |
Applicant |
InMode MD Ltd. |
Tabor Building, Shaar Yokneam, POB 44 |
Yoqneam,
IL
20692
|
|
Applicant Contact |
Ahava Stein |
Correspondent |
A. STEIN- REGULATORY AFFAIRS CONSULTING LTD. |
20 HATA'AS STR., SUITE 102 |
Kfar Saba,
IL
44425
|
|
Correspondent Contact |
Ahava Stein |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/14/2015 |
Decision Date | 07/12/2016 |
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
|
|
|