FDA Product Code
FDA Product Code NHN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.5500
510(k) Clearances — 54 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254024 | MR5 Activ Pro | Multi Radiance Medical, Inc. | 2026-05-19 | Traditional | PDF ↗ |
| K251903 | Erchonia DPN Laser (Model# EVRL) | Erchonia Corporation | 2026-02-19 | Traditional | PDF ↗ |
| K252273 | Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda | 2025-12-12 | Traditional | PDF ↗ |
| K241057 | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | Wuhan Guangdun Technology Co.,Ltd.. | 2025-01-24 | Traditional | PDF ↗ |
| K232813 | Therapy EC, Therapy XT | Dmc Importacao E Exportacao DE Equipamentos Ltda | 2024-12-19 | Traditional | PDF ↗ |
| K231409 | Erchonia FX-405 | Erchonia Corporation | 2023-08-11 | Traditional | PDF ↗ |
| K212189 | FibroLux | Multi Radiance Medical | 2022-09-02 | Traditional | PDF ↗ |
| K221987 | Erchonia GVL | Erchonia Corporation | 2022-09-01 | Traditional | PDF ↗ |
| K203337 | PainTB, PainTJ | Ptech Co., Ltd. | 2022-02-11 | Traditional | PDF ↗ |
| K212595 | Erchonia FX-405 | Erchonia Corporation | 2021-11-12 | Traditional | PDF ↗ |
| K211186 | Erchonia XLR8 | Erchonia Corporation | 2021-10-22 | Traditional | PDF ↗ |
| K191257 | Erchonia EVRL | Erchonia Corporation | 2019-08-08 | Traditional | PDF ↗ |
| K190572 | Erchonia FX-635 | Erchonia Corporation | 2019-06-01 | Traditional | PDF ↗ |
| K180197 | Erchonia FX-635 | Erchonia Corporation | 2018-05-21 | Traditional | PDF ↗ |
| K180585 | Collagentex Rx-6 | Tanses Technologies, Inc. | 2018-05-11 | Traditional | PDF ↗ |
| K171354 | MR4 Laser | Multi Radiance Medical | 2018-01-13 | Traditional | PDF ↗ |
| K162022 | Collagentex Rx-1 | Tanses Technologies, Inc. | 2016-12-22 | Traditional | PDF ↗ |
| K152196 | Erchonia EVRL | Erchonia Corporation | 2016-02-18 | Traditional | PDF ↗ |
| K153052 | Erchonia PL Touch | Erchonia Corporation | 2016-01-04 | Special | PDF ↗ |
| K151816 | TLC-2000 Therapeutic Medical Laser System | Theralase, Inc. | 2015-11-19 | Traditional | PDF ↗ |
| K132940 | ERCHONIA ALLAY | Erchonia Medical, Inc. | 2014-04-14 | Traditional | PDF ↗ |
| K130996 | ERCHONIA EMERGE | Erchonia Medical, Inc. | 2013-09-16 | Traditional | PDF ↗ |
| K130741 | ERCHONIA PL5000 | Erchonia Medical, Inc. | 2013-04-23 | Traditional | PDF ↗ |
| K101430 | MLS-AC DERMA SCANNER | Erchonia Corporation | 2010-06-22 | Traditional | PDF ↗ |
| K100509 | THL1 LASER | Erchonia Corporation | 2010-06-08 | Traditional | PDF ↗ |
| K081166 | LIGHTSTREAM LOW LEVEL LASER | Solica Corporation | 2009-04-03 | Traditional | PDF ↗ |
| K080513 | QLASER SYSTEM | 2035, Inc. | 2009-01-30 | Traditional | PDF ↗ |
| K073689 | LEP2000 THERAPY SYSTEM | International Medical Instruments, Inc. | 2008-11-13 | Traditional | PDF ↗ |
| K072206 | ERCHONIA EML LASER | Erchonia Medical, Inc. | 2008-04-24 | Traditional | PDF ↗ |
| K072551 | LD-I 75 AND LD-I 200 | Meditech International, Inc. | 2008-04-02 | Traditional | PDF ↗ |
| K063574 | LUMINEX LL LASER SYSTEM | Medical Laser Systems, Inc. | 2007-01-29 | Traditional | PDF ↗ |
| K053507 | ELITE ELECTROMED L.I.T.E. 4/1 | Elite Electromedical | 2006-03-15 | Traditional | PDF ↗ |
| K050668 | GRT LITE, MODEL 8-A | Grt Solutions, Inc. | 2006-02-03 | Traditional | PDF ↗ |
| K051631 | EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 | Stargate International, Inc. | 2005-07-27 | Traditional | PDF ↗ |
| K050342 | THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM | Theralase, Inc. | 2005-07-11 | Traditional | PDF ↗ |
| K043353 | OMEGA EXCEL/XP LASER SYSTEM | Advanced Medical Technologies, Inc. | 2005-07-01 | Traditional | PDF ↗ |
| K041565 | LAZRPULSR 4X | Led Healing Light, LLC | 2005-03-03 | Traditional | PDF ↗ |
| K034009 | LAPEX 2000 | Meridian Co., Ltd. | 2005-01-21 | Abbreviated | PDF ↗ |
| K041530 | EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001 | Stargate International, Inc. | 2004-10-14 | Traditional | PDF ↗ |
| K041139 | ERCHONIA EML LASER | Erchonia Medical, Inc. | 2004-09-30 | Traditional | PDF ↗ |
| K032816 | QUANTUM LIGHT THERAPY SYSTEM | Stargate International, Inc. | 2004-03-26 | Traditional | PDF ↗ |
| K023060 | ACCULASER PRO4 | Acculaser, Inc. | 2004-03-19 | Traditional | PDF ↗ |
| K032216 | BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM | Bioptron AG | 2004-02-04 | Traditional | PDF ↗ |
| K033015 | AXIOM BIOLASER LLLT SERIES-3 | Axiom Usa., Inc. | 2003-11-25 | Traditional | PDF ↗ |
| K031499 | DIOBEAM 830 | Soft-Core Texas, Inc. | 2003-09-16 | Traditional | PDF ↗ |
| K030622 | AXIOM BIOLASER LLLT SERIES-1 | Axiom Usa., Inc. | 2003-09-09 | Traditional | PDF ↗ |
| K030692 | POWER LASER 90 | Andi Electromedical Aps | 2003-07-17 | Traditional | PDF ↗ |
| K024310 | NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY | Medx Electronics, Inc. | 2003-03-24 | Traditional | PDF ↗ |
| K030226 | THOR DDII 830CL3 LASER SYSTEM | Thor Intl. | 2003-02-10 | Traditional | PDF ↗ |
| K023935 | TRILUMINA THERAPEUTIC LASER SYSTEM | Texas Applied Biomedical Services | 2003-01-28 | Traditional | PDF ↗ |
| K021985 | MEDX LCS LASER SERIES | Medx Electronics, Inc. | 2002-09-10 | Traditional | PDF ↗ |
| K020657 | ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE | Acculaser, Inc. | 2002-07-29 | Traditional | PDF ↗ |
| K010175 | MICROLIGHT 830 LASER SYSTEM | Microlight Corporation of America | 2002-02-06 | Traditional | PDF ↗ |
| K012580 | ERCHONIA PL2000 | Tuco Innovations, Inc. | 2002-01-17 | Traditional | PDF ↗ |
Product code NHN · Class II · Physical Medicine. Data: openFDA.