510(k) Report

Devices descending from K003183

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K231971Deka Physiq 360El.En S.P.A.20230—
+11K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+11K220268Picosecond Laser System (Model PS10-A and PS10-B)Beijing Adss Development Co., Ltd.20221—
+11K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+11K212573PicoLO PremiumLaseroptek Co., Ltd.20210—
+11K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+11K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+11K182741SculpSureCynosure20195—
+11K172771Epic Pro 940Biolase, Inc.20171—
+11K172144CoolSculpting SystemZeltiq Aesthetics20177—
+11K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+11K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+12K260138LUNE PureHygieneEnamel Pure20260—
+12K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+12K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+12K253007Laser 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—
+12K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+12K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+12K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+12K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+12K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+12K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+13K261701Hemolase 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—
+13K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+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—