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Recall Observatory FDA recall evidence

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

September 19, 2016

Class II

Product summary

Firm
New Star Lasers, Inc.
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

    reason.no_named_rule · v1.0.0

    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.