The following data is part of a premarket notification filed by Lotuxs Medtech (suzhou) Co., Ltd. with the FDA for Powersculp Laser Lipolysis System.
| Device ID | K211402 |
| 510k Number | K211402 |
| Device Name: | Powersculp Laser Lipolysis System |
| Classification | Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| Applicant | Lotuxs Medtech (Suzhou) Co., Ltd. RM301, NW-06, Nanopolis Suzhou, 99 Jinji Lake Avenue, Suzhou Industry Suzhou, CN 215123 |
| Contact | Na Wu |
| Correspondent | Na Wu Lotuxs Medtech (Suzhou) Co., Ltd. RM301, NW-06, Nanopolis Suzhou, 99 Jinji Lake Avenue, Suzhou Industry Suzhou, CN 215123 |
| Product Code | PKT |
| CFR Regulation Number | 878.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-06 |
| Decision Date | 2021-07-30 |