Device product
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
Z-2916-2016
Product summary
- Event
- Event 75048
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 systems
- Official record key
device-enforcement:Z-2916-2016
Official wording
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.
Code information: Serial numbers: ABKK03 ABKK04 ABKM02 ABSG01 ABUP01.
Distribution pattern: US distribution only.
Derived failure modes
-
Unknown
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.