510(k) Report

Devices descending from K162578

4 later devices reach Zerona Z6 OTC through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231474Erchonia Violet ZERONA® Z6 OTCErchonia Corporation20232—
+1K220519Erchonia Zerona Z-BedErchonia Corporation20220—
+2K243811Erchonia Zerona® VZ8Erchonia Corporation20251—
+3K252574Erchonia CLX (Model # CFL)Erchonia Corporation20250—