Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K201738 |
Device Name |
SubNovii Advanced Plasma Technology |
Applicant |
Cartessa Aesthetics |
175 Broadhollow Rd |
Melville,
NY
11747
|
|
Applicant Contact |
Gabe Lubin |
Correspondent |
Hoy and Associates |
3916 North Potsdam Ave |
Souix Falls,
SD
57104
|
|
Correspondent Contact |
Connie Hoy |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/25/2020 |
Decision Date | 09/10/2020 |
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
|