NHN
54 FDA 510(k) clearances · Product code
154 daysmedian time to decision
384 days90th percentile
54clearances measured
FDA profile
- Official device name
- Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Medical specialty
- Physical Medicine
- FDA definition
- A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication. It does not provide therapeutic topical heating. The classification regulation for infrared lamps describes a device that emits energy in the infrared wavelength to provide topical heating and that is not limited to adjunctive use.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MR5 Activ Pro (K254024) | Multi Radiance Medical, Inc. | 2026-05-19 |
| Erchonia DPN Laser (Model# EVRL) (K251903) | Erchonia Corporation | 2026-02-19 |
| Therapy US (K252273) | Dmc Importação E Exportação DE Equipamentos Ltda | 2025-12-12 |
| Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) (K241057) | Wuhan Guangdun Technology Co.,Ltd.. | 2025-01-24 |
| Therapy EC, Therapy XT (K232813) | Dmc Importacao E Exportacao DE Equipamentos Ltda | 2024-12-19 |
| Erchonia FX-405 (K231409) | Erchonia Corporation | 2023-08-11 |
| FibroLux (K212189) | Multi Radiance Medical | 2022-09-02 |
| Erchonia GVL (K221987) | Erchonia Corporation | 2022-09-01 |
| PainTB, PainTJ (K203337) | Ptech Co., Ltd. | 2022-02-11 |
| Erchonia FX-405 (K212595) | Erchonia Corporation | 2021-11-12 |
| Erchonia XLR8 (K211186) | Erchonia Corporation | 2021-10-22 |
| Erchonia EVRL (K191257) | Erchonia Corporation | 2019-08-08 |
| Erchonia FX-635 (K190572) | Erchonia Corporation | 2019-06-01 |
| Erchonia FX-635 (K180197) | Erchonia Corporation | 2018-05-21 |
| Collagentex Rx-6 (K180585) | Tanses Technologies, Inc. | 2018-05-11 |
| MR4 Laser (K171354) | Multi Radiance Medical | 2018-01-13 |
| Collagentex Rx-1 (K162022) | Tanses Technologies, Inc. | 2016-12-22 |
| Erchonia EVRL (K152196) | Erchonia Corporation | 2016-02-18 |
| Erchonia PL Touch (K153052) | Erchonia Corporation | 2016-01-04 |
| TLC-2000 Therapeutic Medical Laser System (K151816) | Theralase, Inc. | 2015-11-19 |
| ERCHONIA ALLAY (K132940) | Erchonia Medical, Inc. | 2014-04-14 |
| ERCHONIA EMERGE (K130996) | Erchonia Medical, Inc. | 2013-09-16 |
| ERCHONIA PL5000 (K130741) | Erchonia Medical, Inc. | 2013-04-23 |
| MLS-AC DERMA SCANNER (K101430) | Erchonia Corporation | 2010-06-22 |
| THL1 LASER (K100509) | Erchonia Corporation | 2010-06-08 |
| LIGHTSTREAM LOW LEVEL LASER (K081166) | Solica Corporation | 2009-04-03 |
| QLASER SYSTEM (K080513) | 2035, Inc. | 2009-01-30 |
| LEP2000 THERAPY SYSTEM (K073689) | International Medical Instruments, Inc. | 2008-11-13 |
| ERCHONIA EML LASER (K072206) | Erchonia Medical, Inc. | 2008-04-24 |
| LD-I 75 AND LD-I 200 (K072551) | Meditech International, Inc. | 2008-04-02 |
| LUMINEX LL LASER SYSTEM (K063574) | Medical Laser Systems, Inc. | 2007-01-29 |
| ELITE ELECTROMED L.I.T.E. 4/1 (K053507) | Elite Electromedical | 2006-03-15 |
| GRT LITE, MODEL 8-A (K050668) | Grt Solutions, Inc. | 2006-02-03 |
| EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 (K051631) | Stargate International, Inc. | 2005-07-27 |
| THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM (K050342) | Theralase, Inc. | 2005-07-11 |
| OMEGA EXCEL/XP LASER SYSTEM (K043353) | Advanced Medical Technologies, Inc. | 2005-07-01 |
| LAZRPULSR 4X (K041565) | Led Healing Light, LLC | 2005-03-03 |
| LAPEX 2000 (K034009) | Meridian Co., Ltd. | 2005-01-21 |
| EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 (K041530) | Stargate International, Inc. | 2004-10-14 |
| ERCHONIA EML LASER (K041139) | Erchonia Medical, Inc. | 2004-09-30 |
| QUANTUM LIGHT THERAPY SYSTEM (K032816) | Stargate International, Inc. | 2004-03-26 |
| ACCULASER PRO4 (K023060) | Acculaser, Inc. | 2004-03-19 |
| BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM (K032216) | Bioptron AG | 2004-02-04 |
| AXIOM BIOLASER LLLT SERIES-3 (K033015) | Axiom Usa., Inc. | 2003-11-25 |
| DIOBEAM 830 (K031499) | Soft-Core Texas, Inc. | 2003-09-16 |
| AXIOM BIOLASER LLLT SERIES-1 (K030622) | Axiom Usa., Inc. | 2003-09-09 |
| POWER LASER 90 (K030692) | Andi Electromedical Aps | 2003-07-17 |
| NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY (K024310) | Medx Electronics, Inc. | 2003-03-24 |
| THOR DDII 830CL3 LASER SYSTEM (K030226) | Thor Intl. | 2003-02-10 |
| TRILUMINA THERAPEUTIC LASER SYSTEM (K023935) | Texas Applied Biomedical Services | 2003-01-28 |
| MEDX LCS LASER SERIES (K021985) | Medx Electronics, Inc. | 2002-09-10 |
| ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE (K020657) | Acculaser, Inc. | 2002-07-29 |
| MICROLIGHT 830 LASER SYSTEM (K010175) | Microlight Corporation of America | 2002-02-06 |
| ERCHONIA PL2000 (K012580) | Tuco Innovations, Inc. | 2002-01-17 |
Track NHN automatically
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