FDA 510(k) Applications Submitted by Karen Liu
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K210542 |
02/24/2021 |
aprevo Transforaminal IBF |
Carlsmed, Inc. |
| K240658 |
03/08/2024 |
1060nm laser body slimming machine |
HeBei JT Medical Co., Ltd. |
| K030904 |
03/24/2003 |
PALAMED |
Heraeus Medical Gmbh Technology |
| K231140 |
04/21/2023 |
aprevo« transforaminal lumbar interbody fusion device |
Carlsmed, Inc. |
| K241332 |
05/10/2024 |
aprevo« anterior and lateral lumbar interbody fusion device; aprevo« anterior lumbar interbody fusion devices with interfixation; aprevo« transforaminal lumbar interbody fusion device |
Carlsmed, Inc. |
| K241477 |
05/24/2024 |
aprevo« anterior lumbar interbody fusion device with interfixation |
Carlsmed, Inc. |
| K231955 |
07/03/2023 |
aprevo« Digital Segmentation |
Carlsmed, Inc. |
| K222009 |
07/07/2022 |
aprevo« anterior lumbar interbody fusion device with interfixation |
Carlsmed, Inc. |
| K222082 |
07/15/2022 |
aprevo« anterior and lateral lumbar interbody fusion devices, aprevo« transforaminal lumbar interbody fusion devices |
Carlsmed, Inc. |
| K222195 |
07/22/2022 |
aprevo« Digital Workflow |
Carlsmed, Inc. |
| K232181 |
07/24/2023 |
Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) |
Hebei JT Medical Co., Ltd. |
| K232282 |
07/31/2023 |
aprevo« anterior and lateral lumbar interbody fusion device, aprevo« transforaminal lumbar interbody fusion device |
Carlsmed, Inc. |
| K242260 |
07/31/2024 |
aprevo« Cervical ACDF; aprevo« Cervical ACDF-X; aprevo« Cervical ACDF-X NO CAM |
Carlsmed, Inc |
| K202250 |
08/10/2020 |
Dermatological Carbon Dioxide Laser Systems |
Zhuolu Jontelaser Manufacturing Technology Co., Ltd |
| K202257 |
08/10/2020 |
Dermatological Diode Laser Systems |
Zhuolu Jontelaser Manufacturing Technology Co., Ltd. |
| K243802 |
12/11/2024 |
aprevo« anterior and lateral lumbar interbody fusion device, aprevo« anterior lumbar interbody fusion device with interfixation |
Carlsmed, Inc. |
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