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510(k) Data Aggregation
K Number
K110342Device Name
YOLO CURVE
Manufacturer
Date Cleared
2011-08-22
(199 days)
Product Code
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
YOLO MEDICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The YOLO CURVE is intended to emit energy in the visible and 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 the temporary relaxation of muscle.
Device Description
The YOLO CURVE has a hand-held treatment probe, is non-invasive, low level visible lamp that provides continuous heat therapy at fixed frequency. The System consists of a Drive Unit, Power Supply, controls and optional treatment probes that contain the visible radiating elements. The YOLO CURVE generator automatically calculates energy output in relation to set treatment parameters. The parameters (treatment time, output power delivered) can be adjusted by using key, treatment specifications and menus. The progress of the treatment is displayed on the LCD display in real time. The YOLO CURVE generator operates simultaneous and independent management of outputs for connecting probes with laser sources from the Red wavelength. The YOLO CURVE generator is supplied with 2 completely independent outputs for using two treatment probes. The LCD displays operating parameters from both channels. This allows two operators to carry out laser therapy independently: just like having two separate instruments.
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