510(k) Report

Devices descending from K032460

569 later devices reach Profile BBL System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+3K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc.2010157—
+3K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+3K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+3K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+3K090525Loi SystemPalomar Medical Products, Inc.20099—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+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—
+3K080932Mosaic Laser SystemLutronic Corporation20086—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+3K072331Radiancy Mistral DeviceRadiancy (Israel), Ltd.20086—
+3K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734—
+3K070392Mosaic Laser SystemLutronic Corporation20078—
+3K063715Juniper Cooling Device XtraJuniper Medical, Inc.200735—
+3K062312Axiom Pulsed Light SystemGeneral Project S.R.L.20060—
+3K062048Aesthera Photopneumatic (PPX) SystemAesthera Corporation20064—
+4K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.20260—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+4K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+4K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+4K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+4K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+4K231394Intense Pulsed Light SystemSmedtrum Medical Technology Co., Ltd.20232—
+4K230077LaserMENeauvia North America20232—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+4K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+4K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K212607DarwinLuvo Medical Technologies, Inc.20210—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.20193—
+4K192331LaseMD LEO Laser SystemLutronic Global20190—
+4K191942MT One DiamondM&T S.R.L.20191—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K182173Joule SystemSciton, Inc20195—
+4K181868SHINY RPL SystemIds, Ltd.20181—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+4K171009LASEMD Laser SystemLutronic Corporation20178—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+4K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+4K151655CO2RE SystemSyneron Medical, Ltd.20151—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K150051ExiliteBTL Industries, Inc.20150—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+4K142093V20 SystemViora, Ltd.201432—
+4K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+4K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+4K133364Picosure WorkstationCynosure, Inc.201451—
+4K133774AtovenBio-Med USA, Inc.20146—
+4K131712A-Tone Ipl SystemYbk Investment, Inc.20140—
+4K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+4K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+4K123573Youlaser CO2 LaserQuanta System Spa201319—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K121346Picosure WorkstationCynosure, Inc.201287—
+4K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+4K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+4K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+4K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc.201157—
+4K103664Primus Aesthetic PlatformPalomar Medical Technologies, Inc.20117—