NHN — Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Class II
FDA product code NHN covers "Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy", a Class II medical device regulated under 21 CFR 890.5500. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NHN
- Device Class
- Class II
- Regulation Number
- 890.5500
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254024 | multi radiance medical | MR5 Activ Pro | May 19, 2026 |
| K251903 | erchonia corporation | Erchonia DPN Laser (Model# EVRL) | February 19, 2026 |
| K252273 | dmc importação e exportação de equipamentos ltda | Therapy US | December 12, 2025 |
| K241057 | wuhan guangdun technology co | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | January 24, 2025 |
| K232813 | dmc importacao e exportacao de equipamentos ltda | Therapy EC, Therapy XT | December 19, 2024 |
| K231409 | erchonia corporation | Erchonia FX-405 | August 11, 2023 |
| K212189 | multi radiance medical | FibroLux | September 2, 2022 |
| K221987 | erchonia corporation | Erchonia GVL | September 1, 2022 |
| K203337 | ptech co | PainTB, PainTJ | February 11, 2022 |
| K212595 | erchonia corporation | Erchonia FX-405 | November 12, 2021 |
| K211186 | erchonia corporation | Erchonia XLR8 | October 22, 2021 |
| K191257 | erchonia corporation | Erchonia EVRL | August 8, 2019 |
| K190572 | erchonia corporation | Erchonia FX-635 | June 1, 2019 |
| K180197 | erchonia corporation | Erchonia FX-635 | May 21, 2018 |
| K180585 | tanses technologies | Collagentex Rx-6 | May 11, 2018 |
| K171354 | multi radiance medical | MR4 Laser | January 13, 2018 |
| K162022 | tanses technologies | Collagentex Rx-1 | December 22, 2016 |
| K152196 | erchonia corporation | Erchonia EVRL | February 18, 2016 |
| K153052 | erchonia corporation | Erchonia PL Touch | January 4, 2016 |
| K151816 | theralase | TLC-2000 Therapeutic Medical Laser System | November 19, 2015 |