FDA Enforcement
Class II
Terminated
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: Z-2916-2016
·
Reported October 12, 2016
Enforcement
- Recall Number
- Z-2916-2016
- Event ID
- 75048
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- New Star Lasers, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 12, 2016
- Initiation Date
- September 19, 2016
- Classification Date
- September 30, 2016
- Termination Date
- December 13, 2016
- Address
- 9085 Foothills Blvd, N/A, Roseville, CA, 95747-7130, United States
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
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 Info
Serial numbers: ABKK03 ABKK04 ABKM02 ABSG01 ABUP01.
Distribution
US distribution only.
Quantity
5 systems