510(k) Report

Devices descending from K032460

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+7K261570Picosure WorkstationCynosure, LLC20260—
+7K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+7K252369Boston Pico755Boston Aesthetics, Inc.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K251730LIA Console (542-7)Leadoptik, Inc.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+7K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+7K2527321927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20251—
+7K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+7K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+7K243957PicoalexWontech Co., Ltd.20250—
+7K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+7K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+7K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+7K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+7K220853PicoWay Laser SystemCandela Corporation20221—
+7K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+7K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+7K221427V-LaserWontech Co., Ltd.20222—
+7K210084SilkroHironic Co., Ltd.20223—
+7K212127PicocaremajestyWontech Co., Ltd.20226—
+7K201773PicohiHironic Co., Ltd.20215—
+7K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+7K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+7K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+7K202041Opera EvoQuanta System Spa20200—
+7K200786Venus EpileveVenus Concept USA, Inc.20200—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+7K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K191855EmFace DeviceInmode MD, Ltd.20191—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+7K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+7K181095RF-ReliefEl Global Trade, Ltd.20181—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+7K173677InMode VLazeInmode MD, Ltd.20183—
+7K172302InMode PLUS SystemInmode MD, Ltd.201713—
+7K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+7K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+7K163222Discovery Pico FamilyQuanta System Spa201630—
+7K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+7K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+7K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+7K153566Magma SystemFormatk Systems, Ltd.20162—
+7K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201526—
+7K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201527—
+7K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+7K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.201430—
+7K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+8K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+8K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+8K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+8K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+8K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+8K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+8K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+8K250734OptiLUV DevicePollogen, Ltd.20250—
+8K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+8K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K250809Stellar M22Lumenis Be, Ltd.20250—
+8K243139Reverso Pro SystemIndiba S. A. U.20250—
+8K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+8K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+8K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+8K233123SilkroHironic Co., Ltd.20241—
+8K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+8K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+8K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+8K233099GladiatorRohrer Aesthetics, LLC20240—
+8K240752Deka ToroEl.En S.P.A.20240—
+8K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+8K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+8K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+8K233143PiXel8-RevealRohrer Aesthetics20240—
+8K232106Air Gap FiberWontech Co., Ltd.20240—
+8K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+8K233147PiXel8-RFRohrer Aesthetics20230—
+8K222790F65 Laser SystemLumenis Be, Ltd.20233—
+8K222221Deka HelixEl.En Electronic Engineering Spa20231—
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+8K211000AcutronIlooda Co,., Ltd.20220—