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510(k) Data Aggregation
K Number
K041679Device Name
COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT
Manufacturer
Date Cleared
2004-12-16
(178 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
ONYX MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To provide topical heating for the temporary rellef of minor muscle and foint pains and stiffness,
the temporary relief of minor joint pain assoclated with arthritls,
the temporary Increase In local blood clrculation where applied,
the relaxation of muscles, and
help muscle spasms, minor sprains and strains, and minor muscular back paln.
Device Description
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