510(k) Report

Devices descending from K972767

1,179 later devices reach Candela Gentlelase GL Dermatological Vascular Lesion Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+8K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+8K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+8K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+8K151306SoleaConvergent Dental, Inc.20151—
+8K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+8K150035V10 systemViora, Ltd.201531—
+8K150326PicoWay Laser SystemCandela Corporation201568—
+8K143105Picosure WorkstationCynosure, Inc.201549—
+8K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+8K142372Pico Way Laser SystemCandela Corpation201470—
+8K140120EPIC 10Biolase, Inc.20141—
+8K140837Lucid LYBio-Med USA, Inc.20140—
+8K140719Picosure WorkstationCynosure, Inc.201450—
+8K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+8K133774AtovenBio-Med USA, Inc.20146—
+8K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+8K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+8K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+8K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+8K130420SOLEAConvergent Dental, Inc.201321
+8K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+8K122200A3F FrationalPollogen, Ltd.20130—
+8K123573Youlaser CO2 LaserQuanta System Spa201319—
+8K123889Acleara, TheraclearTheravant Corporation20130—
+8K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+8K121327Diolase 10SBiolase Technology, Inc.20132—
+8K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+8K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+8K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+8K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+8K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+8K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+8K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+8K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+8K102461FractoraInvasix, Ltd.201124—
+8K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+8K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+8K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+8K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+8K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+8K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+8K091115ECO2 Laser SystemLutronic Corporation200927—
+8K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+8K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+8K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+8K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+8K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+8K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+8K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+8K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+8K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+8K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+8K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+8K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+9K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+9K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260—
+9K260415myLEDmask 2 (MJ-144)Light Tree Ventures Europe B.V.20260—
+9K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+9K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd.20260—
+9K253833Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004…Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+9K253279Feather/numiere 05 06 07 (05)Heat IN A Click, LLC20250—
+9K252187Aura Glide (FC40)Aura Medical, LLC20250—
+9K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd.20251—
+9K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+9K251843Erchonia EVRLErchonia Corporation20250—
+9K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+9K251667LED Light Therapy Mask (M01, M02, M06, M07, M08, M09)Shenzhen Liyoutong Technology Co., Ltd.20250—
+9K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+9K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+9K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+9K251042Light Therapy System (M500, L6)Guangzhou Ahead Intelligent Technology Co., Ltd.20251—
+9K250532Solawave 2-in-1 Skincare Mini (Model: 61043)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+9K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+9K243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.20250—
+9K243393JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP)Shenzhen Ulike Smart Electronics Co., Ltd.20251—
+9K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd.20253—
+9K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+9K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+9K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+9K242349FoLixLumenis Be, Ltd.20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+9K241600DermablateAsclepion Laser Technologies GmbH20240—
+9K233344Regenalase Laser SystemIpg Medical20240—
+9K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+9K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+9K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+9K232708Intense pulsed light therapy deviceHebei Zhemai Technology Co., Ltd.20230—
+9K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+9K223727LavieenWontech Co., Ltd.20234—
+9K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+9K230293TheraFace MaskTherabody, Inc.202316—
+9K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+9K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+9K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—