510(k) Report

Devices descending from K973828

76 later devices reach Prima KTP Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041930Varilite Laser SystemIridex Corporation200475—
+2K091534Lightlas Model 532Lightmed Corp.200972—
+2K073332V-Raser Diode Laser SystemHoya Conbio, Inc.20080—
+2K062074Iridex Wireless FootswitchIridex Corp20060—
+3K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+3K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K261964Echolaser X4Elesta S.P.A20260—
+4K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+4K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+4K222701MANTA LaserSqualus Med, Ltd.20222—
+4K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+4K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+4K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+4K140120EPIC 10Biolase, Inc.20141—
+4K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+4K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+4K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+4K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+4K121327Diolase 10SBiolase Technology, Inc.20132—
+4K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+5K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K233344Regenalase Laser SystemIpg Medical20240—
+5K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+5K193656SkyPulseFotona D.O.O.202011—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K161185LUCERNA Dental LaserViax Dental Lab20160—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K131839DC 7Dc International, LLC20130—
+5K130465EPIC 10SBiolase Technology, Inc.20130—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K251730LIA Console (542-7)Leadoptik, Inc.20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+7K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+8K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+8K232106Air Gap FiberWontech Co., Ltd.20240—
+8K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+9K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+9K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+9K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+10K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+10K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+11K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—