New Star Lasers, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2916-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: September 19, 2016

Date Posted: October 12, 2016

Recall Number: Z-2916-2016

Event ID: 75048

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.

Status: Terminated

Product Quantity: 5 systems

Code Information:

Serial numbers: ABKK03 ABKK04 ABKM02 ABSG01 ABUP01.

Distribution Pattern:

US distribution only.

Voluntary or Mandated:

Voluntary: Firm initiated