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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TYBR HEALTH, INC.
FDA registration
TYBR HEALTH, INC.·2 products·🇺🇸 United States
B3 GEL System
FDA UDI
Tybr Health, Inc.·00860011716730·B3 GEL System - 4 mL / 6 cm
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.
FDA Recall
Terminated
·Strata Skin Sciences, Inc.·Product code GEX·January 23, 2017