510(k) Report

Devices descending from K163009

12 later devices reach Litho through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231718Holmium Medical LaserAllengers Global Healthcare Private Limited20230—
+1K180426Empower H35Quanta System Spa20181—
+1K170331Cyber HoQuanta System Spa20179—
+2K192990Litho EvoQuanta System Spa20190—
+2K172025Litho 60Quanta System Spa20178—
+3K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+3K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa20186—
+3K180423Empower H65Quanta System Spa20181—
+4K242251Litho 60; Litho 100; Litho 150Quanta System Spa20240—
+4K201455Litho 150, Cyber Ho 150Quanta System Spa20203—
+5K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B)…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+5K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—