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510(k) Data Aggregation
K Number
K172639Device Name
PALLAS 308/311 Solid-State UV Laser System
Manufacturer
Laseroptek Co.Ltd
Date Cleared
2017-11-03
(63 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Laseroptek Co.Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use are UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma of affected skin.
Device Description
Laseroptek Co. Ltd.'s PALLAS 308/311 Solid-State UV laser system is a self-contained ultraviolet laser light source and optical energy delivery system that provides targeted energy to the treatment site while avoiding exposure to non-affected tissue. The light source is contained within the protective console. The complete system also includes a hand piece connected to the console via an articulating arm. Timing and dosing parameters and the user interface are controlled through a display on the console. The delivery system allows UV-B light to pass through the hand piece to selectively treat skin legions without exposure to the unwanted skin.
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