510(k) Report

Devices descending from K964074

307 later devices reach Diolite 532 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+1K062074Iridex Wireless FootswitchIridex Corp20060—
+1K041930Varilite Laser SystemIridex Corporation200475—
+1K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+1K021975Lasersystem Beautystar 532Asclepion-Meditec AG200224—
+1K020071Viridis Derma LaserQuantel Medical200292—
+1K982031Oculight GL with the Dermatology HandpieceIridex Corp199822—
+1K981126Ceralas G Frequency Doubled ND: Yag Laser Systems, Ceralas G3Ceram Optec, Inc.19980—
+2K132976AdvatxAdvalight Aps20141—
+2K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+2K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+2K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+2K091534Lightlas Model 532Lightmed Corp.200972—
+2K073332V-Raser Diode Laser SystemHoya Conbio, Inc.20080—
+2K042496Adept Ultralite 532 LaserAdept Medical Concepts200423—
+2K031665Iris Medical Oculight GL/GLX Laser SystemsIridex Corp200321—
+2K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020—
+3K250165PastelleWontech Co., Ltd.20250—
+3K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+3K250189AdvaTxAdvalight Aps20250—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K193656SkyPulseFotona D.O.O.202011—
+3K173285Joule SystemSciton, Inc20185—
+3K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+3K133364Picosure WorkstationCynosure, Inc.201451—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+3K121346Picosure WorkstationCynosure, Inc.201287—
+3K111460Opto Hyalus Green LaserOpto Eletronica S/A20120—
+3K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+3K100558Quanta Diode Laser SystemQuanta System Spa201068—
+3K062624Next Generation LaserAlcon Laboratories200718—
+3K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+4K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+4K261964Echolaser X4Elesta S.P.A20260—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+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—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K233876Unity VCS (8065000296); Unity CS (8065000297)Alcon Laboratories, Inc.202402
+4K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+4K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K222701MANTA LaserSqualus Med, Ltd.20222—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K193266MIINMedico USA, Inc.20210—
+4K201406PicowonWontech Co., Ltd.20200—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K180508Joule SystemSciton, Inc20183—
+4K173199PicoSure WorkstationCynosure, Inc.20189—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+4K162755PicocareWontech Co., Ltd.20179—
+4K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+4K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+4K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+4K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+4K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+4K152856Helios IIILaseroptek Co., Ltd.20165—
+4K160480PicoSure WorkstationCynosure, Inc.201620—
+4K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+4K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+4K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+4K150326PicoWay Laser SystemCandela Corporation201568—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K142877EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Dutch Ophthalmic Research Center International BV20155—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K143105Picosure WorkstationCynosure, Inc.201549—
+4K142372Pico Way Laser SystemCandela Corpation201470—
+4K140120EPIC 10Biolase, Inc.20141—
+4K140719Picosure WorkstationCynosure, Inc.201450—
+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—
+4K11095127+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved…Alcon Research, Ltd.201131
+4K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+4K101285Constellation Vision SystemAlcon Manufacturing, Ltd.2010174
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—