FDASeptember 19, 2016device

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 sapheno...

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

new star lasers

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 sapheno... — Recall Details · AllClear