BEUDAMED
    FDA Recall Open, Classified

    CLARITY II Laser System; Model No. 1110200210.

    Recall: Z-1558-2026 · Initiated January 27, 2026

    Recall

    Recall Number
    Z-1558-2026
    Event Number
    98372
    Firm
    Lutronic Corporation 219 Sowon-Ro; Deogyang Goyang Korea (the Republic of)
    FEI Number
    3004483538
    Product Code
    GEX
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    January 27, 2026
    Posted
    March 12, 2026

    Description

    CLARITY II Laser System; Model No. 1110200210.

    Reason

    Reports of devices sparking/popping and potentially burning patients.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.

    Quantity

    1,525 units