510(k) Report

Devices descending from K951034

314 later devices reach Aura Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+9K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+10K261701Hemolase 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—
+10K213889PicoStarAsclepion Laser Technologies GmbH20220—
+10K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa201918—
+11K202503ChromeQuanta System Spa202012—
+12K253765Vanish ProDdc Technologies, Inc.20260—
+12K250281Deka LotusEl.En S.P.A.20250—
+12K241527Pastelle ProWontech Co., Ltd.20253—
+12K233473Deka LotusEl.En S.P.A.20241—
+12K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+12K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+12K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+13K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—