510(k) Report

Devices descending from K984601

110 later devices reach Candela Gentlelase II Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K241527Pastelle ProWontech Co., Ltd.20253—
+11K240752Deka ToroEl.En S.P.A.20240—
+11K233473Deka LotusEl.En S.P.A.20241—
+11K223404Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4VQuanta System Spa20230—
+11K213726PL-1 Skin Treatment SystemAVAVA, Inc.20220—
+11K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+12K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+12K253344Bellus-QSpeclipse, Inc.20250—
+12K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+12K250165PastelleWontech Co., Ltd.20250—