510(k) Report

Devices descending from K040135

496 later devices reach Thermage Thermacool System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K191685PicoWay Laser SystemCandela Corporation201920—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K183392PicoLO Nd:YAG Picosecond Laser SystemLaseroptek Co., Ltd.20192—
+8K182997enlighten III Laser SystemCutera, Inc.20180—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+8K181272Picocare FamilyWontech Co., Ltd.20188—
+8K173700PICOPLUS Laser SystemLutronic Corporation20187—
+8K170637sensiFirmEl Global Trade, Ltd.20173—
+8K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+8K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+8K161043Profound SystemSyneron Candela Corporation20160—
+8K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+8K153568InMode Plus SystemInmode MD, Ltd.201618—
+8K160368EVO platformQuanta System Spa201636—
+8K152012EVO platformQuanta System Spa201537—
+8K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261570Picosure WorkstationCynosure, LLC20260—
+9K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+9K252369Boston Pico755Boston Aesthetics, Inc.20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+9K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+9K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+9K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+9K243957PicoalexWontech Co., Ltd.20250—
+9K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K240780InMode RF SystemInMode, Ltd.20243—
+9K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+9K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+9K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K230467BTL-899FBTL Industries, Inc.20231—
+9K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+9K220853PicoWay Laser SystemCandela Corporation20221—
+9K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K212127PicocaremajestyWontech Co., Ltd.20226—
+9K201773PicohiHironic Co., Ltd.20215—
+9K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+9K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+9K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+9K191855EmFace DeviceInmode MD, Ltd.20191—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K181095RF-ReliefEl Global Trade, Ltd.20181—
+9K173677InMode VLazeInmode MD, Ltd.20183—
+9K172302InMode PLUS SystemInmode MD, Ltd.201713—
+9K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+9K163222Discovery Pico FamilyQuanta System Spa201630—
+10K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+10K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+10K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+10K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+10K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+10K250734OptiLUV DevicePollogen, Ltd.20250—
+10K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+10K243737Inbella RF SystemInbella Medical, Inc.20250—
+10K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+10K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+10K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+10K240752Deka ToroEl.En S.P.A.20240—
+10K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+10K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+10K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+10K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+10K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+10K183450EmBody SystemInmode MD, Ltd.20198—
+10K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+11K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K230167BACK 4Swims America Corp20230—
+12K230037BACK 3Swims America Corp20230—
+12K213889PicoStarAsclepion Laser Technologies GmbH20220—
+12K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+13K202503ChromeQuanta System Spa202012—
+14K253765Vanish ProDdc Technologies, Inc.20260—
+14K241527Pastelle ProWontech Co., Ltd.20253—
+14K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+14K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+14K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+15K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—