510(k) Report

Devices descending from K935459

403 later devices reach Omron Massager Model HM-45 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+13K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+14K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—