NHN

Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

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)

5 件

其中 Summary 已存档

5 份，可直接下载

FDA 历史累计 510(k)

54 件（全部年份；本站只收录近三年的明细）

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.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

该代码近三年的 510(k)（5 件）

数据窗口为最近三年。最新一件：2026-05-19。

其中 5 件的 Summary 已存档在本站，点 PDF 直接下载；其余给 FDA 官方链接。