Recall Z-2916-2016— New Star Lasers, Inc.
Class II · Terminated
Class II FDA medical device recall by New Star Lasers, Inc., initiated 2016-09-19, terminated 2016-12-13. FDA's recall record names no specific 510(k) clearance for this event. 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. 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..
- Recalling firm
- New Star Lasers, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-19
- Terminated
- 2016-12-13
- Firm location
- Roseville, CA, United States
Product 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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.