FDA 510(k) Applications for Medical Device Product Code: PKT ()

FDA 510(k) Applications for Medical Device Product Code "PKT"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K182741	Cynosure	SculpSure	01/03/2019
K171111	Cynosure, Inc	Sculpsure	06/13/2017
K171992	Cynosure, Inc	SculpSure	09/26/2017
K150230	CYNOSURE, INC.	SculpSure	05/15/2015
K150724	CYNOSURE, INC.	SculpSure	07/01/2015
K160470	CYNOSURE, INC.	SculpSure	07/21/2016
K211681	Dominion Aesthetic Technologies, Inc.	EON	03/30/2022
K180511	Dominion Aesthetic Technologies, Inc.	Eon FR	06/12/2019
K231971	El.En. S.p.A	DEKA PHYSIQ 360	09/26/2023
K192970	HIRONIC Co., Ltd	SLIMUS	12/01/2020
K211402	Lotuxs Medtech (Suzhou) Co., Ltd.	Powersculp laser lipolysis system	07/30/2021
K212331	Rohrer Aesthetics, LLC	BodySculp	11/09/2021
K201731	Shanghai Apolo Medical Technology Co., Ltd.	Diode Laser Body Sculpture System	09/10/2020
K231131	Shanghai Bele Medical Technology Co.,Ltd	Diode Laser Body Sculpture Systems	06/22/2023
K222265	Shanghai Wonderful Opto-Electrics Tech. Co., Ltd.	Diosculpt	09/23/2022
K191068	Wuhan Lotuxs Technology Co., Ltd.	Powersculp laser lipolysis system	07/17/2019