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510(k) Data Aggregation
K Number
K072399Device Name
DEL SOL RED LIGHT THERAPY SYSTEM
Manufacturer
Date Cleared
2008-05-23
(270 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
EDGE SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Del Sol Red Light Therapy System is intended to emit energy in the near infrared spectrum (880nm) to provide topical heating for the purpose of elevating tissue temperature. This device may be used to provide temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm. This device may temporarily increase local blood circulation, and may be used to promote relaxation of the muscle tissue.
Device Description
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