OLI — Fat Reducing Low Level Laser Class II
FDA product code OLI covers "Fat Reducing Low Level Laser", a Class II medical device regulated under 21 CFR 878.5400. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260688 | shenzhen kaiyan medical equipment co | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) | May 4, 2026 |
| K260129 | shenzhen kaiyan medical equipment co | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | April 15, 2026 |
| 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 |