inforMED
NHNClass II

Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy

Physical Medicine · 21 CFR 890.5500

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.

MDR events4All time
Recalls7All time
Registered firms36Currently listed
510(k) clearances54All time

Recent MDR events

4 adverse event reports on file

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Event type breakdown

Injury4

Most-reported manufacturers

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Erchonia (erchmedic)1Erchonia Corporation1Tristar One1Unk1

Recalls

7 recall events for this product code

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Registered firms

36 firms currently registered for this product code

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510(k) clearances

54 clearances for this product code

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