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510(k) Data Aggregation
K Number
K091497Device Name
K-LASER K-1200, MODEL 12 W
Manufacturer
ELTECH, S.R.L.
Date Cleared
2009-08-19
(91 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
ELTECH, S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
Device Description
K-1200 is an infrared therapy table device, easy to transport, usable also without electrical net, thanks to a battery pack. It is composed of a touch screen for managing all the device functions, an emitter, an handpiece for the delivery of light, software and an on/off button to activate and deactivate the infrared emission.
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K Number
K050070Device Name
K-LASER, MODELS 3,4,4D,6D
Manufacturer
ELTECH, S.R.L.
Date Cleared
2005-03-25
(72 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
ELTECH, S.R.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
Device Description
Klaser is an infrared therapy device, composed of emitter, software, probe for the delivery of light and an on/off button to activate and deactivate the infrared emission.
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