NHN
- Product code
- NHN
- Device name
- Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
- Device class
- Class 2
- 21 CFR
- 21 CFR 890.5500
- Medical specialty
- Physical Medicine
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 54
FDA classification 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.
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254024 | 2026-05-19 | Multi Radiance Medical, Inc. | MR5 Activ Pro | |
| K251903 | 2026-02-19 | Erchonia Corporation | Erchonia DPN Laser (Model# EVRL) | |
| K252273 | 2025-12-12 | Dmc Importação E Exportação DE Equipam | Therapy US | |
| K241057 | 2025-01-24 | Wuhan Guangdun Technology Co.,Ltd.. | Enhanced Handheld Pain Relief Laser Instrument (GD-P | |
| K232813 | 2024-12-19 | Dmc Importacao E Exportacao DE Equipam | Therapy EC, Therapy XT |
Official FDA classification page: NHN
Classification and pathway per current FDA publications. Data from openFDA (CC0).