New Star Lasers, Inc. recalls CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excis…

Recall date

September 19, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2914-2016

FDA classification

Class II

Brand / firm

New Star Lasers, Inc.

Sold / distributed

US distribution only.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 atrophic scarring, and; For podiatry, (incision, excision, and coagulation of soft tissue), including. matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas