2023 Biological Device Application Approvals
This list reflects information regarding the applications as of the approval/clearance date. It is not updated with regard to applicant or application status changes. The applications are listed in order by date of approval / clearance in reverse chronological order.
| Tradename/Common Name | Description and Indication for Device | Submission ID | Manufacturer | Clearance Date |
|---|---|---|---|---|
| Procedure Tray - Lipoaspirate fat harvest and injection kit Suction lipoplasty system |
LG PT 15, LG PT 14, LG PT 12, LG PT 04, LG PT 03, LG PT 02 are intended for removal and transfer/reimplantation of autologous adipose tissue without further manipulation for aesthetic body contouring, within the same procedure. In combination with the Lipogems System these devices are intended for use in the following surgical specialties: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery. | BK220775/0 | Hydra Srl Coronati Consulting Srl Via Luigi Gavioli, 3 I-41037 Mirandola (MO) Italy |
01/04/2023 |