510(k) Report

Devices descending from K030142

773 later devices reach Thermacool TC System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K181272Picocare FamilyWontech Co., Ltd.20188—
+9K173700PICOPLUS Laser SystemLutronic Corporation20187—
+9K172771Epic Pro 940Biolase, Inc.20171—
+9K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+9K170936Cutera enlighten III Laser SystemCutera, Inc.201710—
+9K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+9K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201614—
+9K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+9K160368EVO platformQuanta System Spa201636—
+9K152012EVO platformQuanta System Spa201537—
+9K151473NaturaLase PiQo4 - NaturaLase Nd:Y AG 1064 Q-switched Laser with 532 nm accessory and…Focus Medical, LLC201537—
+10K261570Picosure WorkstationCynosure, LLC20260—
+10K260138LUNE PureHygieneEnamel Pure20260—
+10K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+10K251981Boston PICO (Boston PICO)Boston Aesthetics, Inc.20260—
+10K252369Boston Pico755Boston Aesthetics, Inc.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—
+10K252345Picosecond Laser Device (PF131-BI)Risu Medical Technology Co., Ltd.20250—
+10K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+10K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—
+10K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+10K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+10K243957PicoalexWontech Co., Ltd.20250—
+10K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+10K243737Inbella RF SystemInbella Medical, Inc.20250—
+10K242534HandPICO Fractional Laser Handpiece TipVydence Medical20241—
+10K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+10K240386Picosecond Nd:YAG Laser Systems (BL-C10)Shanghai Bele Medical Technology Co.,Ltd20240—
+10K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+10K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+10K230373HELIOS 785 PicoLaseroptek Co., Ltd.20232—
+10K223292TempSure SystemCynosure, LLC20220—
+10K220853PicoWay Laser SystemCandela Corporation20221—
+10K212127PicocaremajestyWontech Co., Ltd.20226—
+10K201773PicohiHironic Co., Ltd.20215—
+10K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+10K203491PicoLO Nd: YAG Picosecond Laser SystemLaseroptek Co., Ltd.20211—
+10K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+10K173677InMode VLazeInmode MD, Ltd.20183—
+10K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+10K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.20178—
+10K163222Discovery Pico FamilyQuanta System Spa201630—
+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—
+11K260017Picosecond Nd:YAG Laser Systems (Model: HS-298)Shanghai Apolo Medical Technology Co., Ltd.20260—
+11K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+11K253829Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+11K252753Vydence Family of LasersVydence Medical Industria E Commercio Ltda20260—
+11K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.20250—
+11K252447Picosecond laser device (BMPS4)Hebei Newangie Technology Co., Ltd.20250—
+11K250041Medical Picosecond ND: YAG Laser System (PZ-6)Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+11K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)Wontech Co., Ltd.20241—
+11K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+11K233007Picosecond Nd:YAG Laser System; PICO LEGENDAmi, Inc.20241—
+11K240752Deka ToroEl.En S.P.A.20240—
+11K240118Picosecond Nd:YAG Laser SystemSmedtrum Medical Technology Co., Ltd.20240—
+11K234104PICOANDY (Q-Switched Nd:YAG Laser)Wontech Co., Ltd.20242—
+11K233018PICOSECOND Nd:YAG Laser SystemIds, Ltd.20232—
+11K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+11K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+11K172144CoolSculpting SystemZeltiq Aesthetics20177—
+11K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+12K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+12K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+13K213889PicoStarAsclepion Laser Technologies GmbH20220—
+13K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+14K202503ChromeQuanta System Spa202012—
+15K253765Vanish ProDdc Technologies, Inc.20260—
+15K241527Pastelle ProWontech Co., Ltd.20253—
+15K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+15K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+15K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+16K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—