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510(k) Data Aggregation

    K Number
    K251464
    Date Cleared
    2025-10-03

    (143 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 TRI-BEAM PRO, TRI-BEAM, Nd: YAG Laser Unit is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

    1064 Wavelength in G, TH mode:

    • 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
    • Treatment of melasma

    1064nm in GN (PTP-Off) mode:

    • Treatment of wrinkles
    • Treatment of mild to moderate inflammatory acne vulgaris

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

    • Tattoo removal: light ink (red,tan, purple, orange, sky blue,green)
    • Removal of Epidermal benign 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
    Device Description

    TRI-BEAM PRO, Nd:YAG Laser unit in the wavelength 1064 nm, 532 nm, 585 nm, and 650 nm is intended for treatment for general dermatology. The TRI-BEAM Series, utilizing Nd:YAG laser optical energy, is based on the principle of selective photothermolysis, enabling targeted treatment of pigmented and vascular lesions, tattoos, wrinkles, acne, and other dermatologic conditions while minimizing damage to surrounding tissue. The system comprises the main unit, a color touch screen, a handpiece, and a foot switch.

    Handpiece Mode

    PTP_ON: Single Pulse
    Laser energy is delivered to the target tissue as a single, continuous pulse.

    PTP_OFF: Dual Pulse
    One pulse is divided into two sub-pulses, delivered sequentially with a short time interval to reduce peak thermal load.

    G Mode
    Beam profile with energy concentrated at the center and gradually tapering toward the periphery, allowing focal energy delivery.

    TH Mode
    Flat-top energy distribution in which the output intensity at the center and periphery is nearly uniform, ensuring consistent tissue exposure.

    GN Mode
    Flat-top energy distribution designed to minimize strong irritation to the skin, even when applied at higher energy levels.

    AI/ML Overview

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