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510(k) Data Aggregation
K Number
K130168Device Name
CL10009 IR LASER
Manufacturer
Date Cleared
2014-01-10
(351 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
CURAE'LASE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K053201Device Name
CURAE'LASE CL1000 IR LASER SYSTEM
Manufacturer
Date Cleared
2005-12-09
(23 days)
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
CURAE'LASE INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cl1000 IR Laser System 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, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
Device Description
The CL1000 IR Laser System is a non-invasive, easy to use, hand-held therapeutic device providing continuous heat therapy. The System is comprised of a Control Unit that houses the electronics and controls the handheld treatment probe, which delivers infrared energy.
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