510(k) Report

Devices descending from K984110

1,034 later devices reach Laserscope Coolspot through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K242349FoLixLumenis Be, Ltd.20240—
+11K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.20240—
+11K233642InMode RF SystemInMode, Ltd.20244—
+11K231971Deka Physiq 360El.En S.P.A.20230—
+11K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.202310—
+11K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+11K182741SculpSureCynosure20195—
+11K172144CoolSculpting SystemZeltiq Aesthetics20177—
+11K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+12K261701Hemolase 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—
+12K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+12K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+12K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+12K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+12K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+12K240780InMode RF SystemInMode, Ltd.20243—
+12K230167BACK 4Swims America Corp20230—
+12K230037BACK 3Swims America Corp20230—
+12K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,Ltd20230—
+12K213889PicoStarAsclepion Laser Technologies GmbH20220—
+12K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+12K181740ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc.201805
+13K243737Inbella RF SystemInbella Medical, Inc.20250—
+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—