510(k) Report

Devices descending from K140388

34 later devices reach Lumenis Pulse 120H through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180423Empower H65Quanta System Spa20181—
+1K163449HyPHo Laser SystemHyper Photonics Srl20170—
+1K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesLumenis, Ltd.2017171
+1K161257MultiPulse HoPLUSAsclepion Laser Technologies GmbH20171—
+1K170331Cyber HoQuanta System Spa20179—
+1K163009LithoQuanta System Spa201612—
+2K260100MOSES Raydar™Boston Scientific Corporation20260—
+2K253633Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+2K252529Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110)…Boston Scientific Corporation20250—
+2K231718Holmium Medical LaserAllengers Global Healthcare Private Limited20230—
+2K213252Dornier ThulioDornier Medtech America, Inc.20220—
+2K202702FLARE Single-Use Surgical Laser FiberRealton (Suzhou) Medical Technology Co., Ltd.20210—
+2K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America2019124
+2K180426Empower H35Quanta System Spa20181—
+2K172025Litho 60Quanta System Spa20178—
+3K252971Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser…C.R. Bard, Inc.20260—
+3K251303Tamburo Thulium Fiber Laser SystemMenovex Medical Technology (Shenzhen) Co., Ltd.20250—
+3K251824Patriot DuoPatriot Laser, LLC20250—
+3K221306SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed…Gyrus Acmi, Inc.202348
+3K211517Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT…Convergent Laser Technologies20210—
+3K211401SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser…Gyrus Acmi, Inc.202171
+3K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+3K192990Litho EvoQuanta System Spa20190—
+3K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa20186—
+4K242251Litho 60; Litho 100; Litho 150Quanta System Spa20240—
+4K242191SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America202437
+4K232568IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation202411
+4K201455Litho 150, Cyber Ho 150Quanta System Spa20203—
+5K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20261—
+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—
+5K251100Ipgtfl-02Ipg Medical Corporation20250—
+5K250504Leonardo DusterCeramoptec GmbH20250—
+6K262877SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…Olympus Surgical Technologies America20260—