510(k) Report

Devices descending from K003715

763 later devices reach Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K123573Youlaser CO2 LaserQuanta System Spa201319—
+5K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+5K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+5K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+5K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+5K113588Spectra Laser SystemLutronic Corporation201282—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+5K102461FractoraInvasix, Ltd.201124—
+5K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+5K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+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—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K090525Loi SystemPalomar Medical Products, Inc.20099—
+5K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K080932Mosaic Laser SystemLutronic Corporation20086—
+5K080374Biosyag Medical SystemBios S.R.L.20082—
+5K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+5K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+5K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+5K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+5K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+6K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+6K252877SANDRO DualWontech Co., Ltd.20250—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+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—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K233224Epilaser ProEpilady 2000, LLC20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+6K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K221761SoleaConvergent Dental, Inc.202201
+6K221427V-LaserWontech Co., Ltd.20222—
+6K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+6K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+6K213428EdgeProBiolase, Inc.20210—
+6K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—