510(k) Report

Devices descending from K951034

314 later devices reach Aura Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192272Wolf445nmA.R.C Laser GmbH20206—
+1K053604Wavelight IdasWavelight Laser Technologie AG200672—
+1K041930Varilite Laser SystemIridex Corporation200475—
+1K021975Lasersystem Beautystar 532Asclepion-Meditec AG200224—
+1K982031Oculight GL with the Dermatology HandpieceIridex Corp199822—
+1K972368Fotona Skinlight Plus ND: Yag SystemMedical Laser Solutions19970—
+1K964074Diolite 532Iriderm Div.1997307—
+1K954905CB Diode/532 Laser SystemContinuum Biomedical, Inc.1996308—
+2K243683Deka BluebeamEl.En S.P.A.20250—
+2K230308Alma HarmonyAlma Lasers, Inc.20232—
+2K210951Leonardo Mini BlueCeramoptec GmbH20210—
+2K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+2K100558Quanta Diode Laser SystemQuanta System Spa201068—
+2K091534Lightlas Model 532Lightmed Corp.200972—
+2K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+2K073332V-Raser Diode Laser SystemHoya Conbio, Inc.20080—
+2K062074Iridex Wireless FootswitchIridex Corp20060—
+2K042496Adept Ultralite 532 LaserAdept Medical Concepts200423—
+2K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+2K031665Iris Medical Oculight GL/GLX Laser SystemsIridex Corp200321—
+2K020071Viridis Derma LaserQuantel Medical200292—
+2K981126Ceralas G Frequency Doubled ND: Yag Laser Systems, Ceralas G3Ceram Optec, Inc.19980—
+3K261964Echolaser X4Elesta S.P.A20260—
+3K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+3K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K222701MANTA LaserSqualus Med, Ltd.20222—
+3K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+3K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+3K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+3K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+3K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+3K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+3K140120EPIC 10Biolase, Inc.20141—
+3K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+3K132976AdvatxAdvalight Aps20141—
+3K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+3K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+3K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+3K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+3K121327Diolase 10SBiolase Technology, Inc.20132—
+3K111460Opto Hyalus Green LaserOpto Eletronica S/A20120—
+3K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+3K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+3K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+3K062624Next Generation LaserAlcon Laboratories200718—
+3K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+3K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+4K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K233876Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc.202402
+4K233344Regenalase Laser SystemIpg Medical20240—
+4K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K193656SkyPulseFotona D.O.O.202011—
+4K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+4K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+4K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+4K173285Joule SystemSciton, Inc20185—
+4K161185LUCERNA Dental LaserViax Dental Lab20160—
+4K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+4K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+4K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV20155—
+4K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+4K133364Picosure WorkstationCynosure, Inc.201451—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+4K131839DC 7Dc International, LLC20130—
+4K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+4K130465EPIC 10SBiolase Technology, Inc.20130—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+4K11095127+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…Alcon Research, Ltd.201131
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+4K101285Constellation Vision SystemAlcon Manufacturing, Ltd.2010174
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+5K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K251730LIA Console (542-7)Leadoptik, Inc.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…Alcon Laboratories, Inc.202402
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—