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Terminated

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

FDA Recall Z-2916-2016 · Posted None

Recalling FirmNew Star Lasers, Inc.
Recall StatusTerminated
Product CodeGEX
Date Initiated2016-09-19
Date Terminated2016-12-13
Product Quantity5 systems

Reason for Recall

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.

Firm Action

Letters sent on September 19, 2016 via US mail advised customers of the unapproved claims that may be in their literature and advised of the approved uses for each device.

Root Cause

Labeling False and Misleading

Distribution Pattern

US distribution only.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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