510(k) Report

Devices descending from K030846

317 later devices reach Candela Smoothbeam Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+2K130459Tria Fan SystemTria Beauty, Inc.20131—
+2K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+2K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+2K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+2K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+3K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+3K141868Tria FanpTria Beauty, Inc.20140—
+3K101321Ematrix CO2Syneron Medical, Ltd.20102—
+3K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+3K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+3K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+3K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+3K070392Mosaic Laser SystemLutronic Corporation20078—
+3K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+3K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+3K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+4K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+4K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+4K123573Youlaser CO2 LaserQuanta System Spa201319—
+4K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+4K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+4K091115ECO2 Laser SystemLutronic Corporation200927—
+4K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+4K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+4K090525Loi SystemPalomar Medical Products, Inc.20099—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K080932Mosaic Laser SystemLutronic Corporation20086—
+4K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+4K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+5K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+5K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+5K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+5K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+5K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+5K193656SkyPulseFotona D.O.O.202011—
+5K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+5K192331LaseMD LEO Laser SystemLutronic Global20190—
+5K182173Joule SystemSciton, Inc20195—
+5K182669Youlaser CO2Quanta System Spa20181—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K173285Joule SystemSciton, Inc20185—
+5K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+5K171009LASEMD Laser SystemLutronic Corporation20178—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K153229SuperbiumBios S.R.L.20162—
+5K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+5K150027CYMAWhitecap Technologies, LLC20150—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+5K132976AdvatxAdvalight Aps20141—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+5K102461FractoraInvasix, Ltd.201124—
+5K110349Clear+Brilliant Laser SystemSolta Medical, Inc.20116—
+5K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+5K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+5K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K244060eCO2 3DLutronic Corporation20250—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K223727LavieenWontech Co., Ltd.20234—
+6K230077LaserMENeauvia North America20232—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K222685NIRA Model 2Dermal Photonics Corp20230—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—