Recall Z-1455-2017— Strata Skin Sciences, Inc.
Class II · Terminated
Class II FDA medical device recall by Strata Skin Sciences, Inc., initiated 2017-01-23, terminated 2017-06-05. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Strata Skin Sciences, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-23
- Terminated
- 2017-06-05
- Firm location
- Carlsbad, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.