510(k) Report

Devices descending from K033437

28 later devices reach Sphinx Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142286NS3000 Holmium Laser SystemNew Star Lasers, Inc.201401
+1K132607NS 2500 Holmium Laser SystemNew Star Lasers, Inc.20141—
+1K132975Sphinx JRAllmed Systems, Inc.20141—
+1K111475Auriga XLStarmedtec GmbH2011514
+1K091909Litho Laser SystemQuanta System Spa200918—
+2K211534RevoLix HTLLisa Laser Products GmbH20220—
+2K131987Multipulse HoplusAsclepion Laser Technologies GmbH20142—
+2K141101LITHOQuanta System Spa201414—
+2K141403Litho DK30Quanta System Spa20142—
+2K121570Auriga QIStarmedtec GmbH20131—
+3K253633Holmium Laser Therapeutic Apparatus (HZ-40)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+3K163449HyPHo Laser SystemHyper Photonics Srl20170—
+3K161257MultiPulse HoPLUSAsclepion Laser Technologies GmbH20171—
+3K163009LithoQuanta System Spa201612—
+3K152220MH01Quanta System Spa20150—
+3K140964Calculase IIKARL STORZ Endoscopy-America, Inc.20140—
+4K231718Holmium Medical LaserAllengers Global Healthcare Private Limited20230—
+4K180426Empower H35Quanta System Spa20181—
+4K170331Cyber HoQuanta System Spa20179—
+5K192990Litho EvoQuanta System Spa20190—
+5K172025Litho 60Quanta System Spa20178—
+6K192600Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60Quanta System Spa20205—
+6K180922Empower H100, Cyber Ho 100, Litho 100Quanta System Spa20186—
+6K180423Empower H65Quanta System Spa20181—
+7K242251Litho 60; Litho 100; Litho 150Quanta System Spa20240—
+7K201455Litho 150, Cyber Ho 150Quanta System Spa20203—
+8K253951Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B)…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20260—
+8K252771Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—