510(k) Report

Devices descending from K961279

1,498 later devices reach Sharplan Lasers, Inc. Ruby Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K121435Silkn BlueHome Skinovations, Ltd.2013125—
+7K123435Ipl Therapy SystemBeijing Sincoheren S&T Development Co, Ltd.20130—
+7K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd.201316—
+7K122237Biophotas LifelightBiophotas, Inc.201371—
+7K123257Emvera DioluxEmvera Technologies, Inc.20123—
+7K121346Picosure WorkstationCynosure, Inc.201287—
+7K121286EPIC 10Biolase Technology, Inc.201231—
+7K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+7K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+7K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+7K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+7K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+7K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+7K113588Spectra Laser SystemLutronic Corporation201282—
+7K111286Quasar CalypsoSilver Bay, LLC201276—
+7K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+7K111483Joule Clearsense Laser SystemSciton, Inc20110—
+7K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+7K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+7K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+7K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc.2011118—
+7K110301Silk'n FXHome Skinovations, Ltd.201166—
+7K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+7K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+7K102857Ahwon's Ipl SystemAhwon Medi Instrument Co., Ltd.20112—
+7K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+7K103415Tanda MaxPharos Life Corporation20110—
+7K100628PlasmaluxlsDaavlin Distributing Co.20100—
+7K091467Baby QuasarSilver Bay, LLC20100—
+7K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+7K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+7K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+7K100558Quanta Diode Laser SystemQuanta System Spa201068—
+7K093168Mediflash and EsteflashDermeo20100—
+7K090744CLAROClrs Technology Corporation20101—
+7K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+7K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+7K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+7K090312Tria Acne Treatment System, Model Ats-1 OtcTria Beauty, Inc.20101—
+7K091664GSD Intense Pulsed Light System, Models: GP666C4, GP666CShenzhen Gsd Tech Co., Ltd.20094—
+7K091115ECO2 Laser SystemLutronic Corporation200927—
+7K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+7K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+7K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+7K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+7K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+7K090221Reaction SystemViora, Ltd.200954—
+7K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+7K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+7K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+7K090525Loi SystemPalomar Medical Products, Inc.20099—
+7K083730IsolazAesthera Corporation20093—
+7K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+7K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+7K080932Mosaic Laser SystemLutronic Corporation20086—
+7K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+7K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+7K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+7K072925Candela-Inolase Serenity Pro PSF SystemInolase, Ltd.20080—
+7K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+7K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+7K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+7K071872VelashapeSyneron Medical, Ltd.2007127—
+7K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemCandela Corp.20071—
+7K071943Serenity Pro PSF SystemInolase 2002, Ltd.20071—
+7K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+7K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+7K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+7K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+7K061603SmoothshapesBiocellulase, Inc.200648—
+7K053611SmoothshapesBicellulase, Inc.200695—
+7K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+7K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+8K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+8K252723Dynamis Pro FamilyFotona D.O.O.20260—
+8K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+8K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+8K261964Echolaser X4Elesta S.P.A20260—
+8K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+8K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K260632Laser Thermal Therapy KitElesta S.P.A20260—
+8K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+8K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+8K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+8K253035IPL Hair Removal Device (SYL001AZ, SYL002AZ)Gu'An Yeolight Smart Electronics Co., Ltd.20250—
+8K250852CoolfaseAsterasys Co., Ltd.20250—
+8K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+8K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+8K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+8K242859VEGAIbramed Equipamentos Médicos20250—
+8K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+8K251327XERFLutronic Corporation202501
+8K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+8K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K250224handLITE (TN19S)iSMART Developments, Ltd.20250—