Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision Recalled by New Star Lasers, Inc. Due to FDA inspection found that customers who had received...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact New Star Lasers, Inc. directly.
Affected Products
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
Quantity: 5 systems
Why Was This 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.
Where Was This Sold?
US distribution only.
About New Star Lasers, Inc.
New Star Lasers, Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report