Device Classification Name |
Massager, Vacuum, Radio Frequency Induced Heat
|
510(k) Number |
K191202 |
Device Name |
CAPENERGY - C100, C200, C300, C400, C50 |
Applicant |
Capenergy Medical SL |
Avinguda Mare de Deu de Montserrat, 41 |
Sant Joan Despi, Barcelona,
ES
08970
|
|
Applicant Contact |
Pilar Sanchez |
Correspondent |
Capenergy Medical SL |
Avinguda Mare de Deu de Montserrat, 41 |
Sant Joan Despi, Barcelona,
ES
08970
|
|
Correspondent Contact |
Pilar Sanchez |
Regulation Number | 878.4400 |
Classification Product Code |
|
Date Received | 05/06/2019 |
Decision Date | 02/11/2020 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|