FDAJanuary 23, 2017device

XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wires may become loose and shorted. Shorted wires may lead to unintentional laser firing.

What to do

FDA enforcement status: Terminated

Brands named

strata skin sciencesstratastrata skin

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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