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New Star Lasers, Inc. recalls CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision,
Recalled October 12, 2016 · FDA recall Z-2914-2016 · New Star Lasers
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. · FDA Class II
Units
44 systems CT3Plus; 47 systems CT3PZ
Sold at
US distribution only.
Description
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.
Product
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
Manufacturer(s)
New Star Lasers, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →