510(k) Report

Devices descending from K180922

6 later devices reach Empower H100, Cyber Ho 100, Litho 100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+2K242251Litho 60; Litho 100; Litho 150Quanta System Spa20240—
+2K231718Holmium Medical LaserAllengers Global Healthcare Private Limited20230—
+2K201455Litho 150, Cyber Ho 150Quanta System Spa20203—
+3K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B)…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+3K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—