OLI
- Product code
- OLI
- Device name
- Fat Reducing Low Level Laser
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.5400
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 33
FDA classification definition
Non-invasive reduction in fat layer for body contouring
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260688 | 2026-05-04 | Shenzhen Kaiyan Medical Equipment Co., | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY- | |
| K260129 | 2026-04-15 | Shenzhen Kaiyan Medical Equipment Co., | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | |
| K243854 | 2026-02-13 | Contour Research, LLC | Contour Light (CL-100) | |
| K252574 | 2025-12-15 | Erchonia Corporation | Erchonia CLX (Model # CFL) | |
| K252786 | 2025-12-01 | Shenzhen Suyzeko Limited. | Led Light Phototherapy Bed (Pro 450/ GY-680A) | |
| K243811 | 2025-01-10 | Erchonia Corporation | Erchonia Zerona® VZ8 | |
| K232977 | 2023-11-21 | Biophotas, Inc. | Biophotas Celluma CONTOUR |
Official FDA classification page: OLI
Classification and pathway per current FDA publications. Data from openFDA (CC0).