FDAFDA · Food and drugs·Recall number Z-2916-2016
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
Published October 12, 2016 · Recall initiated: September 19, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- New Star Lasers, Inc.
- Distributor
- US distribution only.
- Lot
- Serial numbers: ABKK03 ABKK04 ABKM02 ABSG01 ABUP01.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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