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510(k) Data Aggregation
K Number
K021304Device Name
PROLITE PULSED LIGHT SYSTEM
Manufacturer
BIG SKY LASER TECHNOLOGIES, INC.
Date Cleared
2002-07-23
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
BIG SKY LASER TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ProLite™ Pulsed Light System, equipped with the HR handpiece and 600 nanometer filter, is intended for the removal of unwanted hair in all Fitzpatrick skin types.
The ProLite™ Pulsed Light System, equipped with the SR handpiece and 550 or 580 nanometer filters, is intended for the treatment of benign pigmented lesions and the removal of tattoos, the treatment of vascular lesions, and the treatment of shallow facial veins, telangiectasia, facial hemangiomas, and rosacea vascular lesions
The 550 nanometer filter may be more efficient for Types I and II skin. The 580 nanometer filter may be more efficient for Types III and IV skin.
Device Description
The ProLite™ Pulsed Light System uses a Xenon Flash Lamp which is filtered to specified wavelengths for its intended uses. The System consists of a cabinet with power supply, a distilled water cooling system, the microcontroller, an umbilical which attaches to a handpiece which houses the selected filter.
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