New Star Lasers, Inc. recalls ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostas…

Recall date

September 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2916-2016

FDA classification

Class II

Brand / firm

New Star Lasers, Inc.

Sold / distributed

US distribution only.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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