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510(k) Data Aggregation
K Number
K042813Device Name
BIOBEAM NARROW BAND LIGHT THERAPY DEVICES
Manufacturer
LIFE WITHOUT PAIN, LLC
Date Cleared
2005-02-25
(136 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
LIFE WITHOUT PAIN, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Narrow Band, Near-IR Energy, Pain Therapy Devices emit energy in the Near-IR spectrum for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Device Description
The Narrow Band, Near-IR Energy, Pain Therapy Devices use LEDs to generate heat that alleviates pain. Two ranges are employed: 630 nm and 940 nm, depending on the product model, as well as a choice of continuous wave and pulse wave (BioBeam™ models only) modes. The units are available in handheld or mounted configurations.
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