Search Results
Found 2 results
510(k) Data Aggregation
K Number
K150716Device Name
Varaya Sport
Manufacturer
Date Cleared
2015-12-08
(264 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
VARAYA PHOTOCEUTICALS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Varaya Sport Mode 200 is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Device Description
The Varaya Sport (Model 200) is a therapeutic device utilizing high-powered Light Emitting Diodes (LEDs) to distribute specific wavelengths of light energy. The LEDs in the device are: one visible Red (660nm) and one invisible nearInfrared (850nm). The device is handheld .25" above the desired treatment area and operates when connected to an electrical outlet. The device has an on/off button and control panel for a built-in timer and wavelengths. The device has integrated optics to ensure uniform distribution of light energy. The device comes with goggles for safety and a power cord/adaptor. Recommended treatment time is 10-15 minutes per use.
Ask a Question
Ask a specific question about this device
K Number
K112494Device Name
VARAYA AR , VARAYA SPORT
Manufacturer
Date Cleared
2012-05-16
(261 days)
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
VARAYA PHOTOCEUTICALS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Varava Sport Model 200 is indicated/intended for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Device Description
The Varaya Sport Model 200 utilizes high powered Light Emitting Diodes (LEDs) to distribute specific wavelengths of light energy. The LEDs are: one visible Red (660nm) and one invisible nearInfrared (850nm). The device is handheld .25" above the desired treatment area and operates when connected to an electrical outlet. The device has an on/off button and a control panel for a built-in timer and wavelengths. The device has integrated optics to ensure uniform distribution of light energy. The device comes with goggles for safety and a power cord/adapter.
Ask a Question
Ask a specific question about this device
Page 1 of 1