NHN
- 产品代码
- NHN
- 器械名称
- Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 890.5500
- FDA 专业组
- Physical Medicine
- 上市路径
- 需提交 510(k) 上市前通告
- 该代码近三年的 510(k)
- 54 件
FDA 分类定义
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.
该代码近三年的 510(k)（5 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K254024 | 2026-05-19 | Multi Radiance Medical, Inc. | MR5 Activ Pro 摘要 |
| K251903 | 2026-02-19 | Erchonia Corporation | Erchonia DPN Laser (Model# EVRL) 摘要 |
| K252273 | 2025-12-12 | Dmc Importação E Exportação DE Equipam | Therapy US 摘要 |
| K241057 | 2025-01-24 | Wuhan Guangdun Technology Co.,Ltd.. | Enhanced Handheld Pain Relief Laser Instrument (GD-P 摘要 |
| K232813 | 2024-12-19 | Dmc Importacao E Exportacao DE Equipam | Therapy EC, Therapy XT 摘要 |
FDA 官方分类页： NHN
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。