Recall Z-2916-2016 ยท GEX Powered Laser Surgical Instrument
New Star Lasers, Inc.
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
| Date | Sep 19, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling False and Misleading |
| 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. |
| Quantity | 5 systems |
| Distribution | US distribution only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.