510(k) Report

Devices descending from K983984

520 later devices reach Cooltouch V ND:Yag through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K240780InMode RF SystemInMode, Ltd.20243—
+12K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+12K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+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—
+13K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+13K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+13K243737Inbella RF SystemInbella Medical, Inc.20250—
+13K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+13K230167BACK 4Swims America Corp20230—
+13K230037BACK 3Swims America Corp20230—
+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—