510(k) Report

Devices descending from K051167

224 later devices reach Revolix and Revolix JR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160012O-pel Laser and families of probe delivery devicesPrecise Light Surgical20160—
+1K07268250W Ceralas D 1950NM Diode LaserBiolitec, Inc.2008194—
+1K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K213761Joule diVa SystemSciton, Inc20220—
+2K141975Waterlase Iplus SBiolase, Inc.20150—
+2K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+2K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+2K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+2K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+2K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+2K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+3K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+3K193656SkyPulseFotona D.O.O.202011—
+3K173285Joule SystemSciton, Inc20185—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+3K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+3K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+3K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+3K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+3K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+3K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+3K101573Accusculpt II Laser SystemLutronic Corporation20101—
+3K100558Quanta Diode Laser SystemQuanta System Spa201068—
+3K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K261964Echolaser X4Elesta S.P.A20260—
+4K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+4K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+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—
+4K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+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—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+4K180508Joule SystemSciton, Inc20183—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+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—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K140120EPIC 10Biolase, Inc.20141—
+4K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+4K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+4K133774AtovenBio-Med USA, Inc.20146—
+4K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+4K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+4K121327Diolase 10SBiolase Technology, Inc.20132—
+4K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+4K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+4K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+4K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+4K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+4K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+4K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+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—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+5K233344Regenalase Laser SystemIpg Medical20240—
+5K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K223680Eneka ProTermosalud20230—