The following data is part of a premarket notification filed by Wuhan Lotuxs Technology Co., Ltd. with the FDA for Powersculp Laser Lipolysis System.
| Device ID | K191068 |
| 510k Number | K191068 |
| Device Name: | Powersculp Laser Lipolysis System |
| Classification | Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| Applicant | Wuhan Lotuxs Technology Co., Ltd. 5 F, E2 Building, NO 999 Gaoxin Avenue, Future City East Lake High-tech Development Zone, Wu, CN 430206 |
| Contact | Na Wu |
| Correspondent | Jinghua Zhou Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, CN 511660 |
| Product Code | PKT |
| CFR Regulation Number | 878.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-22 |
| Decision Date | 2019-07-17 |