- Nidek's Diode Laser System Wins FDA Approval
FREMONT, Calif., Aug. 22 -- Nidek Inc has been granted 510(k) clearance by the US Food and Drug Administration to use the EpiStar Diode Laser System for hair removal and in the treatment of vascular and pigmented skin lesions.
The system features a proprietary thermo-electric cooling system that cools the skin to 5 degrees C, preventing thermal exposure and decreasing patient discomfort. The EpiStar uses an 810-nm infrared diode laser to treat a two to five millimeter area in a random scanning pattern, which protects the skin and permits homogeneity.
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