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PIOON

Wuhan Pioon Technology Co., Ltd. · Model UTU3-G7W · UDI-DI 06974624062116

EEGNVKGEXILY Prescription
10
510(k) clearances
85
Adverse events
0
Recalls
116
Facilities

Description

The medical diode laser(UTU3-G7W) is a surgical and therapeutic device designated for a wide variety of oral soft tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain.The device utilizes a solid state diode as laser energy source.The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of a footswitch.The UTU3-G7W employ the diodes with wavelengths of 980nm, 650nm and 450nm,it emits laser output energy in the infrared, red and blue spectra respectively.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.