510(k) Report

Devices descending from K020021

740 later devices reach Lyra Surgical Laser System and Accessiories (ND:Yag Configuration) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K160368EVO platformQuanta System Spa201636—
+4K152714Quanta ForteQuanta System Spa201513—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+4K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K141868Tria FanpTria Beauty, Inc.20140—
+4K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+4K124064Young AgainEspansione Marketing S.P.A20131—
+4K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K130199Clarity LPC Laser SystemLutronic Corporation20135—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K113588Spectra Laser SystemLutronic Corporation201282—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K102461FractoraInvasix, Ltd.201124—
+4K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+4K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+4K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+4K080374Biosyag Medical SystemBios S.R.L.20082—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+4K070392Mosaic Laser SystemLutronic Corporation20078—
+4K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+4K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+4K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+4K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+4K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+5K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+5K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+5K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+5K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K251094Alma VeilWontech Co., Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+5K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+5K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+5K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+5K241656Eneka SelectifTermosalud20241—
+5K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+5K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+5K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+5K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K233224Epilaser ProEpilady 2000, LLC20240—
+5K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+5K223680Eneka ProTermosalud20230—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+5K222701MANTA LaserSqualus Med, Ltd.20222—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K221427V-LaserWontech Co., Ltd.20222—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—