510(k) Report

Devices descending from K981351

811 later devices reach Candela Gentlelase GL Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K162781Magma SparkFormatk Systems, Ltd.20160—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K161669Waterlase ExpressBiolase, Inc.201621—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K153229SuperbiumBios S.R.L.20162—
+6K160368EVO platformQuanta System Spa201636—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K152714Quanta ForteQuanta System Spa201513—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K142093V20 SystemViora, Ltd.201432—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K130459Tria Fan SystemTria Beauty, Inc.20131—
+6K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+6K130420SOLEAConvergent Dental, Inc.201321
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K122200A3F FrationalPollogen, Ltd.20130—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+6K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+6K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+6K102461FractoraInvasix, Ltd.201124—
+6K103455Spectra Laser SystemLutronic Corporation201192—
+6K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+6K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+6K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K101321Ematrix CO2Syneron Medical, Ltd.20102—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+6K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+6K093465Fusion SystemEclipsemed Global, Inc.20100—
+6K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+6K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+6K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+6K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K080374Biosyag Medical SystemBios S.R.L.20082—
+6K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+6K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+6K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+6K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+6K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+6K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+6K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K253765Vanish ProDdc Technologies, Inc.20260—
+7K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+7K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+7K250165PastelleWontech Co., Ltd.20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K250809Stellar M22Lumenis Be, Ltd.20250—
+7K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+7K241527Pastelle ProWontech Co., Ltd.20253—
+7K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+7K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+7K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+7K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K231948MediyagMedicreations, LLC20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+7K241600DermablateAsclepion Laser Technologies GmbH20240—
+7K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K233344Regenalase Laser SystemIpg Medical20240—
+7K240752Deka ToroEl.En S.P.A.20240—
+7K233224Epilaser ProEpilady 2000, LLC20240—
+7K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+7K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+7K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+7K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—