PKT — Laser For Disruption Of Adipocyte Cells For Aesthetic Use Class II
FDA product code PKT covers "Laser For Disruption Of Adipocyte Cells For Aesthetic Use", a Class II medical device regulated under 21 CFR 878.5400. Submissions are reviewed by the General, Plastic Surgery panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PKT
- Device Class
- Class II
- Regulation Number
- 878.5400
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K240658 | hebei jt medical co | 1060nm laser body slimming machine | May 13, 2024 |
| K233962 | lightfective | ReBorn (1050nm) | April 16, 2024 |
| K231971 | el.en | DEKA PHYSIQ 360 | September 26, 2023 |
| K231131 | shanghai bele medical technology co | Diode Laser Body Sculpture Systems | June 22, 2023 |
| K222226 | dominion aesthetic technologies | EON | February 17, 2023 |
| K222265 | shanghai wonderful opto-electrics tech.co | Diosculpt | September 23, 2022 |
| K211681 | dominion aesthetic technologies | EON | March 30, 2022 |
| K212331 | rohrer aesthetics | BodySculp | November 9, 2021 |
| K211402 | lotuxs medtech (suzhou) co | Powersculp laser lipolysis system | July 30, 2021 |
| K192970 | hironic co | SLIMUS | December 1, 2020 |
| K201731 | shanghai apolo medical technology co | Diode Laser Body Sculpture System | September 10, 2020 |
| K191068 | wuhan lotuxs technology co | Powersculp laser lipolysis system | July 17, 2019 |
| K180511 | dominion aesthetic technologies | Eon FR | June 12, 2019 |
| K182741 | cynosure | SculpSure | January 3, 2019 |
| K171992 | cynosure | SculpSure | September 26, 2017 |
| K171111 | cynosure | Sculpsure | June 13, 2017 |
| K160470 | cynosure | SculpSure | July 21, 2016 |
| K150724 | cynosure | SculpSure | July 1, 2015 |
| K150230 | cynosure | SculpSure | May 15, 2015 |