FDA product code NHN: Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
NHN is the FDA product code for powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy. It is a Class II device, regulated under 21 CFR 890.5500 and reviewed by the Physical Medicine panel. FDA has cleared 54 510(k) submissions under NHN, 9 in the last five years, from 31 different applicants. The average 510(k) review took 185 days (median 154); 291 days on average over the last three years. FDA has posted 7 recalls for NHN devices.
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.
Classification
| Field | Value |
|---|---|
| Device name | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy |
| Device class | Class II |
| Regulation | 21 CFR 890.5500 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
510(k) clearances per year for NHN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 3 | 144 |
| 2019 | 2 | 88 |
| 2021 | 2 | 136 |
| 2022 | 3 | 310 |
| 2023 | 1 | 88 |
| 2024 | 1 | 463 |
| 2025 | 2 | 212 |
| 2026 | 2 | 199 |
Compare with all 510(k) review times · Search every NHN clearance
Top NHN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Erchonia Corporation | 12 | 2026-02-19 |
| Erchonia Medical, Inc. | 5 | 2014-04-14 |
| Stargate International, Inc. | 3 | 2005-07-27 |
| Multi Radiance Medical | 2 | 2022-09-02 |
| Tanses Technologies, Inc. | 2 | 2018-05-11 |
26 more applicants have NHN clearances. See the full list in Caduvo.
Most recent NHN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254024 | Multi Radiance Medical, Inc. | MR5 Activ Pro | 2026-05-19 | 154 |
| K251903 | Erchonia Corporation | Erchonia DPN Laser (Model# EVRL) | 2026-02-19 | 244 |
| K252273 | Dmc Importação E Exportação DE Equipamentos Ltda | Therapy US | 2025-12-12 | 143 |
| K241057 | Wuhan Guangdun Technology Co.,Ltd.. | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | 2025-01-24 | 281 |
| K232813 | Dmc Importacao E Exportacao DE Equipamentos Ltda | Therapy EC, Therapy XT | 2024-12-19 | 463 |
Recalls for NHN devices
7 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-09-26.
| Year | Recalls |
|---|---|
| 2019 | 7 |
Frequently asked questions
What is FDA product code NHN?
NHN is the FDA product code for powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy. It is a Class II device, regulated under 21 CFR 890.5500 and reviewed by the Physical Medicine panel.
What device class is NHN?
Class II, regulation 21 CFR 890.5500. Typical premarket route: 510(k).
How long does a 510(k) take for product code NHN?
Across 54 cleared submissions the average was 185 days from receipt to decision (median 154).
Which companies have the most NHN clearances?
Erchonia Corporation (12); Erchonia Medical, Inc. (5); Stargate International, Inc. (3); Multi Radiance Medical (2); Tanses Technologies, Inc. (2).
Have NHN devices been recalled?
Yes: 7 product recalls across 6 recall events; the most recent began 2019-09-26.
Next steps
- Run an FDA pathway report with predicate devices for product code NHN
- Run a recall and safety report across every NHN manufacturer
- Watch product code NHN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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