Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K200947 |
Device Name |
InMode System with the Morhpeus8 Applicators |
Applicant |
InMode 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 | 878.4400
|
Classification Product Code |
|
Date Received | 04/08/2020 |
Decision Date | 07/02/2020 |
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
|