FDA 510(k) Applications for Medical Device Product Code "PKT"
| FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
| K182741 |
Cynosure |
SculpSure |
01/03/2019 |
| K171111 |
Cynosure, Inc |
Sculpsure |
06/13/2017 |
| K171992 |
Cynosure, Inc |
SculpSure |
09/26/2017 |
| K150230 |
CYNOSURE, INC. |
SculpSure |
05/15/2015 |
| K150724 |
CYNOSURE, INC. |
SculpSure |
07/01/2015 |
| K160470 |
CYNOSURE, INC. |
SculpSure |
07/21/2016 |
| K211681 |
Dominion Aesthetic Technologies, Inc. |
EON |
03/30/2022 |
| K222226 |
Dominion Aesthetic Technologies, Inc. |
EON |
02/17/2023 |
| K180511 |
Dominion Aesthetic Technologies, Inc. |
Eon FR |
06/12/2019 |
| K231971 |
El.En. S.p.A |
DEKA PHYSIQ 360 |
09/26/2023 |
| K240658 |
HeBei JT Medical Co., Ltd. |
1060nm laser body slimming machine |
05/13/2024 |
| K192970 |
HIRONIC Co., Ltd |
SLIMUS |
12/01/2020 |
| K233962 |
LightFective Ltd. |
ReBorn (1050nm) |
04/16/2024 |
| K211402 |
Lotuxs Medtech (Suzhou) Co., Ltd. |
Powersculp laser lipolysis system |
07/30/2021 |
| K212331 |
Rohrer Aesthetics, LLC |
BodySculp |
11/09/2021 |
| K201731 |
Shanghai Apolo Medical Technology Co., Ltd. |
Diode Laser Body Sculpture System |
09/10/2020 |
| K231131 |
Shanghai Bele Medical Technology Co.,Ltd |
Diode Laser Body Sculpture Systems |
06/22/2023 |
| K222265 |
Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. |
Diosculpt |
09/23/2022 |
| K191068 |
Wuhan Lotuxs Technology Co., Ltd. |
Powersculp laser lipolysis system |
07/17/2019 |
|
|
