BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-2914-2016 · Initiated September 19, 2016

    Recall

    Recall Number
    Z-2914-2016
    Event Number
    75048
    Firm
    New Star Lasers, Inc.
    FEI Number
    1000307100
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    September 19, 2016
    Terminated
    December 13, 2016
    Address
    9085 Foothills Blvd, Roseville, CA, 95747-7130

    Description

    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

    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.

    Action

    Letters sent on September 19, 2016 via US mail advised customers of the unapproved claims that may be in their literature and advised of the approved uses for each device.

    Distribution

    US distribution only.

    Quantity

    44 systems CT3Plus; 47 systems CT3PZ