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U.S. Department of Health and Human Services

Product Classification

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Device powered laser non-thermal instrument with non-heating effect for adjunctive use in pain therapy
Regulation Description Infrared lamp.
Definition 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.
Physical State The device comes in a verity of shapes and sizes. It could be hand held and with weight less than one pound or it could be heavier. It may have a base station with attachments such as different hand piece(s) and touch tone/display screen or other mechanical buttons for user interactions.
Technical Method 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.
Target Area Generally targets body area, over intact skin, known to be associated causing physical pain such as joints and back.
Regulation Medical Specialty Physical Medicine
Review Panel Physical Medicine
Product CodeONH
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Physical Medicine and Neurotherapueutic Devices Branch (PNDB)
Submission Type 510(k)
Regulation Number 890.5500
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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