Erchonia Corporation
FDA 510(k) & PMA Approved Devices — 17 products
Total Devices17
Categories3
Latest FDA decision2026-02-19
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K251903 | Erchonia DPN Laser (Model# EVRL) | NHN | 2026-02-19 | View |
| 510(k) | K252574 | Erchonia CLX (Model # CFL) | OLI | 2025-12-15 | View |
| 510(k) | K251843 | Erchonia EVRL | OLP | 2025-09-12 | View |
| 510(k) | K243811 | Erchonia Zerona® VZ8 | OLI | 2025-01-10 | View |
| 510(k) | K231409 | Erchonia FX-405 | NHN | 2023-08-11 | View |
| 510(k) | K231474 | Erchonia Violet ZERONA® Z6 OTC | OLI | 2023-07-21 | View |
| 510(k) | K221987 | Erchonia GVL | NHN | 2022-09-01 | View |
| 510(k) | K220519 | Erchonia Zerona Z-Bed | OLI | 2022-03-24 | View |
| 510(k) | K212595 | Erchonia FX-405 | NHN | 2021-11-12 | View |
| 510(k) | K211186 | Erchonia XLR8 | NHN | 2021-10-22 | View |
| 510(k) | K192544 | Erchonia Emerald | OLI | 2020-01-13 | View |
| 510(k) | K191257 | Erchonia EVRL | NHN | 2019-08-08 | View |
| 510(k) | K190572 | Erchonia FX-635 | NHN | 2019-06-01 | View |
| 510(k) | K180197 | Erchonia FX-635 | NHN | 2018-05-21 | View |
| 510(k) | K162578 | Zerona Z6 OTC | OLI | 2016-12-16 | View |
| 510(k) | K152196 | Erchonia EVRL | NHN | 2016-02-18 | View |
| 510(k) | K153052 | Erchonia PL Touch | NHN | 2016-01-04 | View |
No matching devices.
Related Clinical Trials
NCT06656325An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of PeriodontitisRECRUITINGNCT06941610An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin LaxityTERMINATEDNCT07121933Evaluation of Erchonia PPL Laser as a Pretreatment Adjunct to Enhance Standard Erchonia Red Laser for the Relief of PainCOMPLETEDNCT07600203A Double-blind, Placebo-controlled Evaluation of the Effect of the Erchonia® EVRL on Chronic Jaw Pain Arising From TMJRECRUITING