Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect for Adjunctive Use in Pain Therapy

What Is It?

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.

How Is NHN Classified?

Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy is FDA product code NHN, Class 2, 21 CFR 890.5500.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 281 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 7 recalls under this product code since 2019. None was by a company in China. The root causes the FDA records most often are Process control (5) and Device Design (2).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.