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510(k) Data Aggregation

    K Number
    K213557
    Device Name
    Finexel
    Manufacturer
    Date Cleared
    2022-04-12

    (155 days)

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

    SNJ Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Finexel CO2 laser system is intended for use in non-fractionated mode for Incision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in Dermatology, Plastic surgery, Gynecology, Neurosurgery, and in Podiatry.
    Device Description
    Finexel CO2 Laser System
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    K Number
    K202288
    Device Name
    Finebeam
    Manufacturer
    Date Cleared
    2021-11-19

    (464 days)

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

    SNJ Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Finebeam Dual is a surgical laser instrument intended to provide laser energy in two different operation modes (Qswitched (QSW) and long pulse (LPS)) with 1064nm or 532 nm wavelength per use in a variety of dermatological procedures. Each function is intended for: - 1) QSW mode with 1064nm single or 1064nm photoacoustic double pulse (PDP) function - Removal dark ink (black, blue, and brown) tattoos; - Treatment melasma, treatment nevus of Ota; - Treatment common nevi; - Removal of lightening of unwanted hair; and - Skin resurfacing procedures for the treatment of acne scars and wrinkles - 2) QSW mode with 532nm single function - Removal of light ink (red, tan, purple, and orange) tattoos; - Treatment of vascular lesions including, but not limited to port-wine stains, spider angioma, cherry angioma; - Treatment of pigmented lesions including, but not limited to cafe-au-Lait birthmarks, solar lentigines, Becker's nevi, freckles, common nevi, and nevus spilus; - Treatment of seborrheic keratosis: - Treatment of post-inflammatory hyperpigmentation; and - Skin resurfacing procedures for the treatment of acne scars and wrinkles in the QSW mode function; 3) QSW mode with 1064nm Non-Q function - Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of Pseudofolliculitis Barbae (PFB). The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin; - Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, cherry angioma, Hemangiomas, warts, telangiectasias, rosacea, leg veins, Coagulation and hemostasis of soft tissue; and - Treatment of wrinkles 4) LPS mode - Removal of unwanted hair, for stable long term or permanent hair reduction and treatment of PFB. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin; - Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangiomas, warts, telangiectasias, rosacea, leg veins, and spider veins; - Coagulation and hemostasis of soft tissue: - Treatment of wrinkles and acne vulgaris
    Device Description
    The Finebeam Dual is designed to use neodymium-doped yttrium aluminum garnet (Nd:YAG) to transform and generate high voltage sources for the optical resonator, and the atoms in the source are activated to amplify and emit laser light.
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