510(k) Report

Devices descending from K022381

519 later devices reach Profile 1320 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+11K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+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—
+12K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+12K243737Inbella RF SystemInbella Medical, Inc.20250—
+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—