The following data is part of a premarket notification filed by Shanghai Wonderful Opto-electrics Tech. Co., Ltd. with the FDA for Diosculpt.
| Device ID | K222265 |
| 510k Number | K222265 |
| Device Name: | Diosculpt |
| Classification | Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| Applicant | Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. 2F, Building 11, Lane 1175, Tongpu Rd. Shanghai, CN 200333 |
| Contact | Lily Zhou |
| Correspondent | Lily Zhou Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. 2F, Building 11, Lane 1175, Tongpu Rd. Shanghai, CN 200333 |
| Product Code | PKT |
| CFR Regulation Number | 878.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-28 |
| Decision Date | 2022-09-23 |