510(k) Report

Devices descending from K962109

1,499 later devices reach SLS Chromos 694 QD Ruby Laser to BE Renamed Mehl QD Ruby Laser System for Hair… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K122966XP200Btl Industries, Ltd.20131—
+6K121435Silkn BlueHome Skinovations, Ltd.2013125—
+6K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+6K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+6K122237Biophotas LifelightBiophotas, Inc.201371—
+6K123257Emvera DioluxEmvera Technologies, Inc.20123—
+6K121346Picosure WorkstationCynosure, Inc.201287—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+6K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+6K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+6K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+6K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+6K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+6K113588Spectra Laser SystemLutronic Corporation201282—
+6K111286Quasar CalypsoSilver Bay, LLC201276—
+6K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+6K111483Joule Clearsense Laser SystemSciton, Inc20110—
+6K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+6K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+6K110301Silk'n FXHome Skinovations, Ltd.201166—
+6K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+6K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+6K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+6K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+6K103415Tanda MaxPharos Life Corporation20110—
+6K100628PlasmaluxlsDaavlin Distributing Co.20100—
+6K091467Baby QuasarSilver Bay, LLC20100—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K093168Mediflash and EsteflashDermeo20100—
+6K090744CLAROClrs Technology Corporation20101—
+6K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+6K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+6K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+6K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+6K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+6K091115ECO2 Laser SystemLutronic Corporation200927—
+6K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+6K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+6K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+6K090221Reaction SystemViora, Ltd.200954—
+6K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+6K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+6K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+6K090525Loi SystemPalomar Medical Products, Inc.20099—
+6K083730IsolazAesthera Corporation20093—
+6K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+6K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+6K080932Mosaic Laser SystemLutronic Corporation20086—
+6K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+6K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+6K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+6K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+6K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+6K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+6K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+6K071872VelashapeSyneron Medical, Ltd.2007127—
+6K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+6K071943Serenity Pro PSF SystemInolase 2002, Ltd.20071—
+6K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+6K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+6K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+6K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+6K061603SmoothshapesBiocellulase, Inc.200648—
+6K053611SmoothshapesBicellulase, Inc.200695—
+6K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+6K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K261964Echolaser X4Elesta S.P.A20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+7K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K260632Laser Thermal Therapy KitElesta S.P.A20260—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K253035IPL Hair Removal Device (SYL001AZ, SYL002AZ)Gu'An Yeolight Smart Electronics Co., Ltd.20250—
+7K250852CoolfaseAsterasys Co., Ltd.20250—
+7K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+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—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K251327XERFLutronic Corporation202501
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—