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510(k) Data Aggregation

    K Number
    K253123
    Device Name
    CuRAS hybrid
    Manufacturer
    Date Cleared
    2025-11-20

    (56 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CuRAS hybrid Nd:YAG laser system indicated for: the incision,excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

    532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces):

    • Tattoo removal: light ink (red, tan, purple, orange, skyblue, green)
    • Removal of Epidermal Pigmented Lesions
    • Removal of Minor Vascular Lesions including but not limited to telangiectasias
    • Treatment of Lentigines
    • Treatment of Cafe-Au-Lait
    • Treatment of Seborrheic Keratoses
    • Treatment of Post Inflammatory Hyper-Pigmentation
    • Treatment of Becker's Nevi, Freckles and Nevi Spilus

    1064nm Wavelength:

    • Tattoo removal: dark ink (black, blue and brown)
    • Removal of Nevus of Ota
    • Removal or lightening of unwanted hair with or without adjuvant preparation.
    • Treatment of Common Nevi
    • Skin resurfacing procedures for the treatment of acne scars and wrinkle
    Device Description

    The CuRAS hybrid is indicated for: the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis, at wavelength of 532 nm and 1064 nm. In addition, optional dye handpieces provide output at wavelength of 585 nm and 650 nm.

    The CuRAS hybrid system consists of a main unit, power cable, an articulated arm that transmits the laser energy, interchangeable handpieces, a footswitch, key switch, remote interlock connector, and operator/patient protective eyewear. The laser output is user-controlled via the footswitch.

    CuRAS hybrid consists of the following components:

    • Main Unit
    • Handpieces x2
    • Handpieces(Optional) x3
    • Articulated Arm
    • Accessories: Power Cable, Footswitch, Key Switch, Goggles for Operator and Patients, Remote Interlock Connector
    AI/ML Overview

    N/A

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