510(k) Report

Devices descending from K003765

741 later devices reach Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+5K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K171702Exciplex308nmClarteis20175—
+5K171648BM.IrisBluecore Co., Ltd.20172—
+5K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K163222Discovery Pico FamilyQuanta System Spa201630—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K162781Magma SparkFormatk Systems, Ltd.20160—
+5K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K161669Waterlase ExpressBiolase, Inc.201621—
+5K152737Lite TouchFocus Medical, LLC20160—
+5K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+5K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+5K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+5K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+5K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K142093V20 SystemViora, Ltd.201432—
+5K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K140120EPIC 10Biolase, Inc.20141—
+5K140837Lucid LYBio-Med USA, Inc.20140—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K133774AtovenBio-Med USA, Inc.20146—
+5K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K130501IntensifEndymed Medical, Ltd.201457—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+5K124064Young AgainEspansione Marketing S.P.A20131—
+5K131758Surgen UPollogen, Ltd.20135—
+5K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+5K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+5K123573Youlaser CO2 LaserQuanta System Spa201319—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K121327Diolase 10SBiolase Technology, Inc.20132—
+5K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+5K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+5K091115ECO2 Laser SystemLutronic Corporation200927—
+5K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+5K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+5K090525Loi SystemPalomar Medical Products, Inc.20099—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K080932Mosaic Laser SystemLutronic Corporation20086—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+5K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+6K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K250809Stellar M22Lumenis Be, Ltd.20250—
+6K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+6K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+6K243488Vmat ProTermosalud20250—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—