Erchonia CLX (Model # CFL)
FDA 510(k) K252574 · Erchonia Corporation
510(k) numberK252574
Submission
- Device name
- Erchonia CLX (Model # CFL)
- Applicant
- Erchonia Corporation
Fountain Inn, SC, US - Received
- August 14, 2025
- Decision date
- December 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLI – Fat Reducing Low Level Laser
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5400
- Specialty
- General, Plastic Surgery
Non-invasive reduction in fat layer for body contouring
Other 510(k)s with product code OLI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)OLI · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 05/04/2026SE |
| K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )OLI · Traditional | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 04/15/2026SE |
| K243854 | Contour Light (CL-100)OLI · Special | Contour Research, LLC | 02/13/2026SE |
| K252786 | Led Light Phototherapy Bed (Pro 450/ GY-680A)OLI · Traditional | Shenzhen Suyzeko Limited. | 12/01/2025SE |
| K243811 | Erchonia Zerona® VZ8OLI · Traditional | Erchonia Corporation | 01/10/2025SE |
| K232977 | Biophotas Celluma CONTOUROLI · Traditional | Biophotas, Inc. | 11/21/2023SE |
| K231474 | Erchonia Violet ZERONA® Z6 OTCOLI · Traditional | Erchonia Corporation | 07/21/2023SE |
| K220519 | Erchonia Zerona Z-BedOLI · Traditional | Erchonia Corporation | 03/24/2022SE |
| K213534 | PHantom TrilogyOLI · Traditional | Resurgeonz, LLC | 03/11/2022SE |
| K202955 | Contour Light CL-100OLI · Traditional | Contour Research, LLC | 05/19/2021SE |
More from Contour Research, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K251903 | Erchonia DPN Laser (Model# EVRL)NHN · Traditional | 02/19/2026SE |
| K251843 | Erchonia EVRLOLP · Traditional | 09/12/2025SE |
| K243811 | Erchonia Zerona® VZ8OLI · Traditional | 01/10/2025SE |
| K231409 | Erchonia FX-405NHN · Traditional | 08/11/2023SE |
| K231474 | Erchonia Violet ZERONA® Z6 OTCOLI · Traditional | 07/21/2023SE |
| K221987 | Erchonia GVLNHN · Traditional | 09/01/2022SE |
| K220519 | Erchonia Zerona Z-BedOLI · Traditional | 03/24/2022SE |
| K212595 | Erchonia FX-405NHN · Traditional | 11/12/2021SE |
| K211186 | Erchonia XLR8NHN · Traditional | 10/22/2021SE |
| K192544 | Erchonia EmeraldOLI · Traditional | 01/13/2020SE |
Questions and answers
When was Erchonia CLX (Model # CFL) cleared by the FDA?
Erchonia CLX (Model # CFL) (K252574) received a 510(k) decision of Substantially Equivalent on December 15, 2025, 123 days after the submission was received.
What is the product code of K252574?
The FDA product code is OLI – Fat Reducing Low Level Laser, a Class II (moderate risk) device regulated under 21 CFR 878.5400.