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

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

FDA 510(k) Number	Applicant	Device Name	Decision Date
K113810	ALMA LASERS INC.	MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES	03/08/2012
K150138	ASPEN LASER SYSTEMS, LLC	Aspen Laser Systems Therapy Laser System	05/08/2015
K110375	BLUESHINE SRL	BLUESHINE'S GOLD SERIES	02/23/2012
K103626	CUTERA, INC.	CUTERA GENESISPLUS LASER SYSTEM	04/05/2011
K153164	ERCHONIA MEDICAL, INC.	LunulaLaser	06/03/2016
K190034	Footdocprenur, LLC	REMY Medical Therapy Laser System	05/15/2019
K113702	FOTONA D.D.	FOTONA XP ND: YAG LASER SYSTEM	03/28/2012
K121508	FOTONA D.D.	LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N	12/12/2012
K110370	LIGHT AGE, INC.	Q-CLEAR	09/15/2011
K123014	LITECURE, LLC	LITECURE THERAPY SYSTEM MODEL LTS-1500	03/29/2013
K113843	LUTRONIC CORPORATION	FREEDOM ND: YAG LASER SYSTEM	09/27/2012
K103338	NEW STAR LASERS, INC.	COOLTOUCH	11/01/2011
K093547	PINPOINTE USA, INC.	PINPOINTE FOOTLASER	10/15/2010
K111483	SCITON, INC.	JOULE CLEARSENSE LASER SYSTEM	12/07/2011
K120938	SHEAUMANN LASER, INC	THE PL-1064 LASER SYSTEM	09/24/2012
K221363	ShenB Co Ltd	AF Laser	07/20/2022
K241116	TerasysD&C Inc.	Onycho Laser V	07/22/2024
K211265	ToeFX, Inc.	TFX-LT2000 Therapy Light	11/17/2022