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Panels › General, Plastic Surgery › Product code PDZ · Class 2

Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Regulation 878.4810

1510(k)s in 12 months (19 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
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Top companies in PDZ

Company510(k)sRecalls
Fotona D.D.20
Alma Lasers, Inc.10
Aspen Laser Systems, LLC10
Blueshine Srl10
Cutera, Inc.10
Erchonia Medical, Inc.10
Footdocprenur, LLC10
Hyperion Medical01
Light Age, Inc.10
Litecure, LLC10
Decided510(k)Device and applicantCode
Mar 9, 2026K253960Medicell Mycosis Laser (MCML24004)
Medicell Healthcare Co.,LTD, KR
PDZ
Jul 22, 2024K241116Onycho Laser V
Terasysd&C, Inc., KR
PDZ
Nov 17, 2022K211265TFX-LT2000 Therapy Light
Toefx, Inc., CA
PDZ
Jul 20, 2022K221363AF Laser
ShenB Co., Ltd., KR
PDZ
May 15, 2019K190034REMY Medical Therapy Laser System
Footdocprenur, LLC
PDZ
Jun 3, 2016K153164LunulaLaser
Erchonia Medical, Inc.
PDZ
May 8, 2015K150138Aspen Laser Systems Therapy Laser System
Aspen Laser Systems, LLC
PDZ
Mar 29, 2013K123014LITECURE THERAPY SYSTEM MODEL LTS-1500
Litecure, LLC
PDZ
Dec 12, 2012K121508LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
Fotona D.D., SI
PDZ
Sep 27, 2012K113843FREEDOM ND: YAG LASER SYSTEM
Lutronic Corporation
PDZ
Sep 24, 2012K120938THE PL-1064 LASER SYSTEM
Sheaumann Laser, Inc.
PDZ
Mar 28, 2012K113702FOTONA XP ND: YAG LASER SYSTEM
Fotona D.D., SI
PDZ
Mar 8, 2012K113810MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES
Alma Lasers, Inc.
PDZ
Feb 23, 2012K110375BLUESHINE'S GOLD SERIES
Blueshine Srl, IT
PDZ
Dec 7, 2011K111483JOULE CLEARSENSE LASER SYSTEM
Sciton, Inc
PDZ
Nov 1, 2011K103338COOLTOUCH
New Star Lasers, Inc.
PDZ
Sep 15, 2011K110370Q-CLEAR
Light Age, Inc.
PDZ
Apr 5, 2011K103626CUTERA GENESISPLUS LASER SYSTEM
Cutera, Inc.
PDZ
Oct 15, 2010K093547PINPOINTE FOOTLASER
Pinpointe USA, Inc.
PDZ

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