FDA-Device2017-04-05Class II
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.
Strata Skin Sciences, Inc.
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.
Sold states
USA (nationwide) Distribution
Affected count
US - 1000 , Foreign - 612
Manufactured in
2375 Camino Vida Roble Ste B, Carlsbad, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1455-2017Don't want to check this manually?
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