PKT
- Product code
- PKT
- Device name
- Laser For Disruption Of Adipocyte Cells For Aesthetic Use
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.5400
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- GMP exempt
- 510(k) clearances (last 3 years)
- 19
FDA classification definition
Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240658 | 2024-05-13 | Hebei JT Medical Co., Ltd. | 1060nm laser body slimming machine | |
| K233962 | 2024-04-16 | Lightfective , Ltd. | ReBorn (1050nm) | |
| K231971 | 2023-09-26 | El.En S.P.A. | DEKA PHYSIQ 360 |
Official FDA classification page: PKT
Classification and pathway per current FDA publications. Data from openFDA (CC0).