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
Recall
- Recall Number
- Z-2916-2016
- Event Number
- 75048
- Firm
- New Star Lasers, Inc.
- FEI Number
- 1000307100
- Product Code
- GEX
- Status
- Terminated
- Root Cause
- Labeling False and Misleading
- Initiated
- September 19, 2016
- Terminated
- December 13, 2016
- Address
- 9085 Foothills Blvd, Roseville, CA, 95747-7130
Description
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 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.
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.
US distribution only.
5 systems