Erchonia Corporation

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
26
Inspections
7
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K251903Erchonia DPN Laser (Model# EVRL)February 19, 2026
K252574Erchonia CLX (Model # CFL)December 15, 2025
K251843Erchonia EVRLSeptember 12, 2025
K243811Erchonia Zerona® VZ8January 10, 2025
K231409Erchonia FX-405August 11, 2023
K231474Erchonia Violet ZERONA® Z6 OTCJuly 21, 2023
K221987Erchonia GVLSeptember 1, 2022
K220519Erchonia Zerona Z-BedMarch 24, 2022
K212595Erchonia FX-405November 12, 2021
K211186Erchonia XLR8October 22, 2021
K192544Erchonia EmeraldJanuary 13, 2020
K191257Erchonia EVRLAugust 8, 2019
K190572Erchonia FX-635June 1, 2019
K180197Erchonia FX-635May 21, 2018
K162578Zerona Z6 OTCDecember 16, 2016
K152196Erchonia EVRLFebruary 18, 2016
K153052Erchonia PL TouchJanuary 4, 2016
K150446Erchonia Zerona 6 headed scanner EZ6May 21, 2015
K143007Erchonia Zerona Z6 OTCJanuary 15, 2015
K142042ERCHONIA SHLOctober 21, 2014