Device Classification Name |
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
|
510(k) Number |
K222265 |
Device Name |
Diosculpt |
Applicant |
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. |
2F, Building 11, Lane 1175, Tongpu Rd. |
Shanghai,
CN
200333
|
|
Applicant Contact |
Lily Zhou |
Correspondent |
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. |
2F, Building 11, Lane 1175, Tongpu Rd. |
Shanghai,
CN
200333
|
|
Correspondent Contact |
Lily Zhou |
Regulation Number | 878.5400
|
Classification Product Code |
|
Date Received | 07/28/2022 |
Decision Date | 09/23/2022 |
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
|
|
|