OLI — Fat Reducing Low Level Laser Class II
Classification Details
- Product Code
- OLI
- Device Class
- Class II
- Regulation Number
- 878.5400
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Non-invasive reduction in fat layer for body contouring
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243854 | contour research | Contour Light (CL-100) | February 13, 2026 |
| K252574 | erchonia corporation | Erchonia CLX (Model # CFL) | December 15, 2025 |
| K252786 | shenzhen suyzeko limited | Led Light Phototherapy Bed (Pro 450/ GY-680A) | December 1, 2025 |
| K243811 | erchonia corporation | Erchonia Zerona® VZ8 | January 10, 2025 |
| K232977 | biophotas | Biophotas Celluma CONTOUR | November 21, 2023 |
| K231474 | erchonia corporation | Erchonia Violet ZERONA® Z6 OTC | July 21, 2023 |
| K220519 | erchonia corporation | Erchonia Zerona Z-Bed | March 24, 2022 |
| K213534 | resurgeonz | PHantom Trilogy | March 11, 2022 |
| K202955 | contour research | Contour Light CL-100 | May 19, 2021 |
| K202361 | ward photonics | UltraSlim Digital, UltraSmooth Digital | December 18, 2020 |
| K192275 | ir technology | invisa-RED ELITE | August 19, 2020 |
| K192544 | erchonia corporation | Erchonia Emerald | January 13, 2020 |
| K180338 | ward photonics | Cellulize | September 21, 2018 |
| K172111 | vevazz | Vevazz LED | November 22, 2017 |
| K170709 | yolo medical | CURVE Laser System | June 6, 2017 |
| K162578 | erchonia corporation | Zerona Z6 OTC | December 16, 2016 |
| K160880 | ward photonics | Photonica Professional | September 23, 2016 |
| K150446 | erchonia corporation | Erchonia Zerona 6 headed scanner EZ6 | May 21, 2015 |
| K143741 | yolo medical | Lipofina Laser System | April 24, 2015 |
| K143007 | erchonia corporation | Erchonia Zerona Z6 OTC | January 15, 2015 |