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New Star Lasers, Inc. recalls ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemos
Recalled October 12, 2016 · FDA recall Z-2916-2016 · New Star Lasers
Hazard
FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications. · FDA Class II
Units
5 systems
Sold at
US distribution only.
Description
FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
Product
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities, and; for laser assisted lipolysis
Manufacturer(s)
New Star Lasers, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →