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Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Regulation 890.5500

3510(k)s in 12 months (54 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in NHN

Company510(k)sRecalls
Erchonia Corporation120
Theralase, Inc.27
Erchonia Medical, Inc.50
Multi Radiance Medical30
Stargate International, Inc.30
Acculaser, Inc.20
Axiom Usa., Inc.20
Medx Electronics, Inc.20
Tanses Technologies, Inc.20
2035, Inc.10
Decided510(k)Device and applicantCode
May 19, 2026K254024MR5 Activ Pro
Multi Radiance Medical, Inc.
NHN
Feb 19, 2026K251903Erchonia DPN Laser (Model# EVRL)
Erchonia Corporation
NHN
Dec 12, 2025K252273Therapy US
Dmc Importação E Exportação DE Equipamentos Ltda, BR
NHN
Jan 24, 2025K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)
Wuhan Guangdun Technology Co.,Ltd.., CN
NHN
Dec 19, 2024K232813Therapy EC, Therapy XT
Dmc Importacao E Exportacao DE Equipamentos Ltda, BR
NHN
Aug 11, 2023K231409Erchonia FX-405
Erchonia Corporation
NHN
Sep 2, 2022K212189FibroLux
Multi Radiance Medical
NHN
Sep 1, 2022K221987Erchonia GVL
Erchonia Corporation
NHN
Feb 11, 2022K203337PainTB, PainTJ
Ptech Co., Ltd., KR
NHN
Nov 12, 2021K212595Erchonia FX-405
Erchonia Corporation
NHN
Oct 22, 2021K211186Erchonia XLR8
Erchonia Corporation
NHN
Aug 8, 2019K191257Erchonia EVRL
Erchonia Corporation
NHN
Jun 1, 2019K190572Erchonia FX-635
Erchonia Corporation
NHN
May 21, 2018K180197Erchonia FX-635
Erchonia Corporation
NHN
May 11, 2018K180585Collagentex Rx-6
Tanses Technologies, Inc., CA
NHN
Jan 13, 2018K171354MR4 Laser
Multi Radiance Medical
NHN
Dec 22, 2016K162022Collagentex Rx-1
Tanses Technologies, Inc., CA
NHN
Feb 18, 2016K152196Erchonia EVRL
Erchonia Corporation
NHN
Jan 4, 2016K153052Erchonia PL Touch
Erchonia Corporation
NHN
Nov 19, 2015K151816TLC-2000 Therapeutic Medical Laser System
Theralase, Inc., CA
NHN
Apr 14, 2014K132940ERCHONIA ALLAY
Erchonia Medical, Inc.
NHN
Sep 16, 2013K130996ERCHONIA EMERGE
Erchonia Medical, Inc.
NHN
Apr 23, 2013K130741ERCHONIA PL5000
Erchonia Medical, Inc.
NHN
Jun 22, 2010K101430MLS-AC DERMA SCANNER
Erchonia Corporation
NHN
Jun 8, 2010K100509THL1 LASER
Erchonia Corporation
NHN
Apr 3, 2009K081166LIGHTSTREAM LOW LEVEL LASER
Solica Corporation, CA
NHN
Jan 30, 2009K080513QLASER SYSTEM
2035, Inc.
NHN
Nov 13, 2008K073689LEP2000 THERAPY SYSTEM
International Medical Instruments, Inc.
NHN
Apr 24, 2008K072206ERCHONIA EML LASER
Erchonia Medical, Inc.
NHN
Apr 2, 2008K072551LD-I 75 AND LD-I 200
Meditech International, Inc.
NHN
Jan 29, 2007K063574LUMINEX LL LASER SYSTEM
Medical Laser Systems, Inc.
NHN
Mar 15, 2006K053507ELITE ELECTROMED L.I.T.E. 4/1
Elite Electromedical
NHN
Feb 3, 2006K050668GRT LITE, MODEL 8-A
Grt Solutions, Inc.
NHN
Jul 27, 2005K051631EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001
Stargate International, Inc.
NHN
Jul 11, 2005K050342THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM
Theralase, Inc., CA
NHN
Jul 1, 2005K043353OMEGA EXCEL/XP LASER SYSTEM
Advanced Medical Technologies, Inc.
NHN
Mar 3, 2005K041565LAZRPULSR 4X
Led Healing Light, LLC
NHN
Jan 21, 2005K034009LAPEX 2000
Meridian Co., Ltd.
NHN
Oct 14, 2004K041530EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001
Stargate International, Inc.
NHN
Sep 30, 2004K041139ERCHONIA EML LASER
Erchonia Medical, Inc.
NHN
Mar 26, 2004K032816QUANTUM LIGHT THERAPY SYSTEM
Stargate International, Inc.
NHN
Mar 19, 2004K023060ACCULASER PRO4
Acculaser, Inc.
NHN
Feb 4, 2004K032216BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM
Bioptron AG
NHN
Nov 25, 2003K033015AXIOM BIOLASER LLLT SERIES-3
Axiom Usa., Inc.
NHN
Sep 16, 2003K031499DIOBEAM 830
Soft-Core Texas, Inc.
NHN
Sep 9, 2003K030622AXIOM BIOLASER LLLT SERIES-1
Axiom Usa., Inc.
NHN
Jul 17, 2003K030692POWER LASER 90
Andi Electromedical Aps
NHN
Mar 24, 2003K024310NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY
Medx Electronics, Inc., CA
NHN
Feb 10, 2003K030226THOR DDII 830CL3 LASER SYSTEM
Thor Intl.
NHN
Jan 28, 2003K023935TRILUMINA THERAPEUTIC LASER SYSTEM
Texas Applied Biomedical Services
NHN

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