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510(k) Data Aggregation

    K Number
    K221766
    Device Name
    Solon
    Date Cleared
    2024-01-05

    (567 days)

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

    LMG Lasers Comercio, Importacao e Exportacao Ltda

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Solon is intended to be use in dermatology, cosmetic surgery, and other surgical applications according to the different handpieces. The specific indications should reference to the indications of each handpiece. 1) Pro handpiece: · Incision, excision, ablation, vaporization of soft tissue · The non-ablative treatment of facial wrinkles 2) Multistation Handpiece: · Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 3) Vektra QS Handpiece: · Tattoo Removal: Dark Ink: (Black & Blue) · Nevus of Ota · Skin resurfacing procedures for the treatment of acne scars and wrinkles 4) IPL Handpiece: The Intense Pulsed Light wavelengths are 515-1200 nm · Multiwave: 650-1200 nm The removal of unwanted hair from skin types I-V, and to effect stable long-term, or permanent hair reduction in skin types I - V through selective targeting of melanin in hair follicules. · Expert Light: 570- 1200nm The treatment of benign pigment (epidermal and cutaneous) lesions, such as warts. · Expert Light: 515-1200nm The treatment of benign vascular lesions including port wine stains, hemangiomas, facial, truncal anf leg telangiectasias, rosacea, melasma, angiomas and spider aglormas, polkilorderma of civatte, leg veins and venous malformations.
    Device Description
    The Solon system is a modular multifunction device. The equipment can be used in dermatology, and aesthetic surgery according to the different handpieces. The Solon system has five laser handpieces of Er:YAG laser, Long Pulse Nd:YAG Laser, and Q-Switch Nd:YAG Laser, and two IPL handpiece.
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