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510(k) Data Aggregation
K Number
K091285Device Name
AL T LASER, MODEL AVI HPLL-12
Manufacturer
AVICENNA LASER TECHNOLOGY, INC.
Date Cleared
2009-07-28
(88 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
AVICENNA LASER TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ALT Laser, Model AVI HPLL-12 is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.
Device Description
The system will produce a 980nm infrared and a 650 nm red visible laser light in overlapping patterns. The two types of light will be mixed such that the visible 650 nm light becomes a reasonable indicator of the invisible infrared 980nm light. The 650 nm visible aiming laser light will be sensed and if the light is absent, it will lock out the infrared 980nm light and alert the operator.
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K Number
K031612Device Name
ALT LASER, MODEL VTR 75
Manufacturer
AVICENNA LASER TECHNOLOGY, INC.
Date Cleared
2003-12-11
(203 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
AVICENNA LASER TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ALT Laser, Model VTR75 is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.
Device Description
The system will produce a 980nm infrared and a 660 nm red visible laser light in overlapping patterns. The two types of light will be mixed such that the visible 660 nm light becomes a reasonable indicator of the invisible infrared 980nm light. The 660 nm visible aiming laser light will be sensed and if the light is absent, it will lock out the infrared 980nm light and alert the operator.
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