510(k) Report

Devices descending from K032460

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+8K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+8K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+8K200234Surgical laser fibersQuanta System Spa20202—
+8K183450EmBody SystemInmode MD, Ltd.20198—
+8K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+8K163197Cook Holmium Laser FiberCook Incorporated20170—
+8K162781Magma SparkFormatk Systems, Ltd.20160—
+8K160470SculpSureCynosure, Inc.201620—
+8K160259ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201615—
+8K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+8K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+8K150724SculpSureCynosure, Inc.201521—
+8K150230SculpSureCynosure, Inc.201521—
+9K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K251334New Doublo 2.0Hironic Co., Ltd.20250—
+9K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+9K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+9K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+9K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+9K242349FoLixLumenis Be, Ltd.20240—
+9K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+9K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+9K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+9K211681EONDominion Aesthetic Technologies, Inc.20221—
+9K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+9K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+9K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.20196—
+9K190743Venus BlissVenus Concept USA, Inc.20194—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+9K171111SculpsureCynosure, Inc.201710—
+9K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+9K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+10K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+10K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+10K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+10K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+10K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+10K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+10K230167BACK 4Swims America Corp20230—
+10K230037BACK 3Swims America Corp20230—
+10K222226EONDominion Aesthetic Technologies, Inc.20230—
+10K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20220—
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+10K212331BodySculpRohrer Aesthetics, LLC20211—
+10K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.20210—
+10K192970SlimusHironic Co., Ltd.20200—
+10K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.20201—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+10K171992SculpSureCynosure, Inc.20178—
+10K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+11K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—
+11K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+11K231971Deka Physiq 360El.En S.P.A.20230—
+11K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+11K202503ChromeQuanta System Spa202012—
+11K182741SculpSureCynosure20195—
+11K172144CoolSculpting SystemZeltiq Aesthetics20177—
+12K253765Vanish ProDdc Technologies, Inc.20260—
+12K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+12K241527Pastelle ProWontech Co., Ltd.20253—
+12K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+12K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+13K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—