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

FDA product code NHN · 52 cleared devices

Class 2 Physical Medicine
Regulation
21 CFR 890.5500
Review panel
PM
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2002-01-17 – 2026-05-19

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.

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