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510(k) Data Aggregation
K Number
K063745Device Name
MEDILASER, MODEL 1000
Manufacturer
Date Cleared
2007-04-23
(125 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
LASER THERA, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MediLaser is an infrared lamp that is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.
Device Description
The MediLaser is a portable, hand held. AC operated non-invasive, low level infrared lamp that provides continuous heat therapy at a fixed frequency.
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K Number
K060153Device Name
ACUMED LASER, MODEL 1000
Manufacturer
Date Cleared
2006-09-29
(252 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
LASER THERA, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The AcuMed Laser is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied and the relaxation of muscles.
Device Description
The AcuMed Laser is a portable, hand held, AC operated non-invasive, low level infrared lamp that provides continuous heat therapy at a fixed frequency.
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Ask a specific question about this device
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