FDA 510(k) Applications for Medical Device Product Code "NHN"
(Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K080513 | 2035, INC. | QLASER SYSTEM | 01/30/2009 |
| K020657 | ACCULASER, INC. | ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE | 07/29/2002 |
| K023060 | ACCULASER, INC. | ACCULASER PRO4 | 03/19/2004 |
| K043353 | ADVANCED MEDICAL TECHNOLOGIES, INC. | OMEGA EXCEL/XP LASER SYSTEM | 07/01/2005 |
| K030692 | ANDI ELECTROMEDICAL APS | POWER LASER 90 | 07/17/2003 |
| K030622 | AXIOM USA. INC | AXIOM BIOLASER LLLT SERIES-1 | 09/09/2003 |
| K033015 | AXIOM USA. INC | AXIOM BIOLASER LLLT SERIES-3 | 11/25/2003 |
| K032216 | BIOPTRON AG | BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM | 02/04/2004 |
| K053507 | ELITE ELECTROMEDICAL | ELITE ELECTROMED L.I.T.E. 4/1 | 03/15/2006 |
| K152196 | ERCHONIA CORPORATION | Erchonia EVRL | 02/18/2016 |
| K191257 | Erchonia Corporation | Erchonia EVRL | 08/08/2019 |
| K212595 | Erchonia Corporation | Erchonia FX-405 | 11/12/2021 |
| K231409 | Erchonia Corporation | Erchonia FX-405 | 08/11/2023 |
| K180197 | Erchonia Corporation | Erchonia FX-635 | 05/21/2018 |
| K190572 | Erchonia Corporation | Erchonia FX-635 | 06/01/2019 |
| K221987 | Erchonia Corporation | Erchonia GVL | 09/01/2022 |
| K153052 | ERCHONIA CORPORATION | Erchonia PL Touch | 01/04/2016 |
| K211186 | Erchonia Corporation | Erchonia XLR8 | 10/22/2021 |
| K101430 | ERCHONIA CORPORATION | MLS-AC DERMA SCANNER | 06/22/2010 |
| K100509 | ERCHONIA CORPORATION | THL1 LASER | 06/08/2010 |
| K130741 | ERCHONIA MEDICAL INC | ERCHONIA PL5000 | 04/23/2013 |
| K132940 | ERCHONIA MEDICAL, INC. | ERCHONIA ALLAY | 04/14/2014 |
| K130996 | ERCHONIA MEDICAL, INC. | ERCHONIA EMERGE | 09/16/2013 |
| K041139 | ERCHONIA MEDICAL, INC. | ERCHONIA EML LASER | 09/30/2004 |
| K072206 | ERCHONIA MEDICAL, INC. | ERCHONIA EML LASER | 04/24/2008 |
| K050668 | GRT SOLUTIONS, INC. | GRT LITE, MODEL 8-A | 02/03/2006 |
| K073689 | INTERNATIONAL MEDICAL INSTRUMENTS, INC. | LEP2000 THERAPY SYSTEM | 11/13/2008 |
| K041565 | LED HEALING LIGHT LLC | LAZRPULSR 4X | 03/03/2005 |
| K063574 | MEDICAL LASER SYSTEMS INC | LUMINEX LL LASER SYSTEM | 01/29/2007 |
| K072551 | MEDITECH INTERNATIONAL, INC. | LD-I 75 AND LD-I 200 | 04/02/2008 |
| K021985 | MEDX ELECTRONICS, INC. | MEDX LCS LASER SERIES | 09/10/2002 |
| K024310 | MEDX ELECTRONICS, INC. | NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY | 03/24/2003 |
| K034009 | MERIDIAN CO., LTD. | LAPEX 2000 | 01/21/2005 |
| K010175 | MICROLIGHT CORPORATION OF AMERICA | MICROLIGHT 830 LASER SYSTEM | 02/06/2002 |
| K212189 | Multi Radiance Medical | FibroLux | 09/02/2022 |
| K171354 | Multi Radiance Medical | MR4 Laser | 01/13/2018 |
| K203337 | Ptech Co., Ltd. | PainTB, PainTJ | 02/11/2022 |
| K031499 | SOFT-CORE TEXAS, INC. | DIOBEAM 830 | 09/16/2003 |
| K081166 | SOLICA CORPORATION | LIGHTSTREAM LOW LEVEL LASER | 04/03/2009 |
| K051631 | STARGATE INTERNATIONAL, INC. | EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 | 07/27/2005 |
| K041530 | STARGATE INTERNATIONAL, INC. | EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 | 10/14/2004 |
| K032816 | STARGATE INTERNATIONAL, INC. | QUANTUM LIGHT THERAPY SYSTEM | 03/26/2004 |
| K162022 | Tanses Technologies inc. | Collagentex Rx-1 | 12/22/2016 |
| K180585 | Tanses Technologies inc. | Collagentex Rx-6 | 05/11/2018 |
| K023935 | TEXAS APPLIED BIOMEDICAL SERVICES | TRILUMINA THERAPEUTIC LASER SYSTEM | 01/28/2003 |
| K050342 | THERALASE INC. | THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM | 07/11/2005 |
| K151816 | Theralase Inc. | TLC-2000 Therapeutic Medical Laser System | 11/19/2015 |
| K030226 | THOR INTL. | THOR DDII 830CL3 LASER SYSTEM | 02/10/2003 |
| K012580 | TUCO INNOVATIONS, INC. | ERCHONIA PL2000 | 01/17/2002 |
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