PKT
19 FDA 510(k) clearances · Product code
97 daysmedian time to decision
405 days90th percentile
19clearances measured
FDA profile
- Official device name
- Laser For Disruption Of Adipocyte Cells For Aesthetic Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5400
- Medical specialty
- General, Plastic Surgery
- Flags
- GMP exempt
- FDA definition
- Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
- Adverse events (MAUDE)
- 2017: 10 · 2018: 16 · 2019: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| 1060nm laser body slimming machine (K240658) | Hebei JT Medical Co., Ltd. | 2024-05-13 |
| ReBorn (1050nm) (K233962) | Lightfective , Ltd. | 2024-04-16 |
| DEKA PHYSIQ 360 (K231971) | El.En S.P.A. | 2023-09-26 |
| Diode Laser Body Sculpture Systems (K231131) | Shanghai Bele Medical Technology Co.,Ltd | 2023-06-22 |
| EON (K222226) | Dominion Aesthetic Technologies, Inc. | 2023-02-17 |
| Diosculpt (K222265) | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2022-09-23 |
| EON (K211681) | Dominion Aesthetic Technologies, Inc. | 2022-03-30 |
| BodySculp (K212331) | Rohrer Aesthetics, LLC | 2021-11-09 |
| Powersculp laser lipolysis system (K211402) | Lotuxs Medtech (Suzhou) Co., Ltd. | 2021-07-30 |
| SLIMUS (K192970) | Hironic Co., Ltd. | 2020-12-01 |
| Diode Laser Body Sculpture System (K201731) | Shanghai Apolo Medical Technology Co., Ltd. | 2020-09-10 |
| Powersculp laser lipolysis system (K191068) | Wuhan Lotuxs Technology Co., Ltd. | 2019-07-17 |
| Eon FR (K180511) | Dominion Aesthetic Technologies, Inc. | 2019-06-12 |
| SculpSure (K182741) | Cynosure | 2019-01-03 |
| SculpSure (K171992) | Cynosure, Inc. | 2017-09-26 |
| Sculpsure (K171111) | Cynosure, Inc. | 2017-06-13 |
| SculpSure (K160470) | Cynosure, Inc. | 2016-07-21 |
| SculpSure (K150724) | Cynosure, Inc. | 2015-07-01 |
| SculpSure (K150230) | Cynosure, Inc. | 2015-05-15 |
Track PKT automatically
Every clearance here is in the API, with alerts when new ones post.