Product code
NHN: Powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
FDA product code · Class II · Physical Medicine
Key facts
| Product code | NHN |
|---|---|
| Device | Powered light based laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy |
| Device class | Class II |
| Regulation number | 890.5500 |
| Review panel | Physical Medicine |
| Medical specialty | Physical Medicine |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | 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… |
At a glance
- 10–99 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database