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510(k) Data Aggregation
K Number
K022341Device Name
TERABYTE 2000 HAIR REMOVER
Manufacturer
Date Cleared
2003-01-27
(193 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
TERABYTE CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TERABYTE 2000 System is intended for hair removal and permanent hair reduction.
Device Description
TERABYTE 2000 Hair Remover delivers pulsed infrared laser light at a wavelength of 810 nm with selectable pulse duration of 5 - 50 ms, and a selectable fluence of 10 -65 J/cm². The laser pulses are capable of generating a maximum pulse repetition frequency of 1 Hz by several arrays of diode lasers located in the handpiece. The complete system consists of a console and handpiece connected to the system by an umbilical. In standard use, the handpiece is pressed against the patient's skin and a pulse of light is delivered. To initiate energy output the system requires the set up of the touch screen , and concurrent activation of the following : the handpiece skin touch switch, handpiece trigger , and footswitch. The cryogen is splayed from the top of the handpiece to provide active skin cooling. Laser parameters and other system features are controlled from the touch screen on top of the console, which provides an interface to the system computer.
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