Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K231790 |
Device Name |
The InMode System with the Morpheus8 Applicators |
Applicant |
InMode Ltd. |
Tabor Building, Shaar Yokneam POB 44 |
Yokneam Iillit,
IL
2069200
|
|
Applicant Contact |
Suhair Francis |
Correspondent |
Hogan Lovells US LLP |
1735 Market Street, Suite 2300 |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice M. Hogan |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/20/2023 |
Decision Date | 07/20/2023 |
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
|