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510(k) Data Aggregation

    K Number
    K241672
    Device Name
    COPRO 3
    Date Cleared
    2024-09-06

    (87 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMT Engineering Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Non-fractional mode is indicated for incision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. Fractional mode is indicated for only ablative skin resurfacing.
    Device Description
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    K Number
    K230340
    Device Name
    Lucas Plus
    Date Cleared
    2023-05-04

    (86 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMT Engineering Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Lucas Plus Nd : YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for Coagulation and hemostasis. 532nm Wavelength Tattoo removal light ink (red, tan, purple, orange, sky blue,) Removal of Epidermal Pigmented Lesions, Minor Vascular Lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Sebrorrheic Keratoses, Becker's Nevi, Freckles, Treatment of Post Inflammatory Hyperpigmentation (PIH) 1064nm Wavelength: Tattoo removal: dark ink (black, blue, green ) Removal of Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation Treatment of Common Nevi, Melasma, Skin resurfacing procedures for the treatment of acne scars, wrinkle
    Device Description
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