FDASeptember 19, 2016device

CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris; For back acne and atrop...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

new star lasers

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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