FDA Product Code
FDA Product Code PKT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.5400
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240658 | 1060nm laser body slimming machine | Hebei JT Medical Co., Ltd. | 2024-05-13 | Traditional | PDF ↗ |
| K233962 | ReBorn (1050nm) | Lightfective , Ltd. | 2024-04-16 | Traditional | PDF ↗ |
| K231971 | DEKA PHYSIQ 360 | El.En S.P.A. | 2023-09-26 | Traditional | PDF ↗ |
| K231131 | Diode Laser Body Sculpture Systems | Shanghai Bele Medical Technology Co.,Ltd | 2023-06-22 | Traditional | PDF ↗ |
| K222226 | EON | Dominion Aesthetic Technologies, Inc. | 2023-02-17 | Traditional | PDF ↗ |
| K222265 | Diosculpt | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2022-09-23 | Traditional | PDF ↗ |
| K211681 | EON | Dominion Aesthetic Technologies, Inc. | 2022-03-30 | Traditional | PDF ↗ |
| K212331 | BodySculp | Rohrer Aesthetics, LLC | 2021-11-09 | Traditional | PDF ↗ |
| K211402 | Powersculp laser lipolysis system | Lotuxs Medtech (Suzhou) Co., Ltd. | 2021-07-30 | Traditional | PDF ↗ |
| K192970 | SLIMUS | Hironic Co., Ltd. | 2020-12-01 | Traditional | PDF ↗ |
| K201731 | Diode Laser Body Sculpture System | Shanghai Apolo Medical Technology Co., Ltd. | 2020-09-10 | Traditional | PDF ↗ |
| K191068 | Powersculp laser lipolysis system | Wuhan Lotuxs Technology Co., Ltd. | 2019-07-17 | Traditional | PDF ↗ |
| K180511 | Eon FR | Dominion Aesthetic Technologies, Inc. | 2019-06-12 | Traditional | PDF ↗ |
| K182741 | SculpSure | Cynosure | 2019-01-03 | Traditional | PDF ↗ |
| K171992 | SculpSure | Cynosure, Inc. | 2017-09-26 | Traditional | PDF ↗ |
| K171111 | Sculpsure | Cynosure, Inc. | 2017-06-13 | Traditional | PDF ↗ |
| K160470 | SculpSure | Cynosure, Inc. | 2016-07-21 | Traditional | PDF ↗ |
| K150724 | SculpSure | Cynosure, Inc. | 2015-07-01 | Traditional | PDF ↗ |
| K150230 | SculpSure | Cynosure, Inc. | 2015-05-15 | Traditional | PDF ↗ |
Product code PKT · Class II · General, Plastic Surgery. Data: openFDA.