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510(k) Data Aggregation

    K Number
    K240314
    Device Name
    MULA (K2-A1)
    Manufacturer
    Guangzhou Ciellulu Photoelectric Technology Co., Ltd
    Date Cleared
    2024-08-21

    (201 days)

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

    Guangzhou Ciellulu Photoelectric Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MULA is intended for aesthetic and dermatological skin procedure applications by using multi-filtered Intense Pulsed Light/ Dye Pulsed Light. Intended Use for the 400-1200mm (including 8 filters) Light: 1) Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). 2) Cutaneous lesions, including warts, scars and striae. 3) Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, poikiloderma of Civatte, facial and leg veins and venous malformations. 4) Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles. 5) Mild to moderate inflammatory Acne (Acne vulgaris) Note: Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.
    Device Description
    The MULA is a multi-application, multi-technology system, with an IPL&DPL handpiece and 8 different filters: 515nm/ 560mm/ 615nm/ 640mm/ 695nm/ Acne Filter (Notch filter 400-600 and 800-1200) and Vascular Filter (Notch filter 530-650 & 900-1200), and it also equips two precision treatment heads (38x10mm and 8mm diameter).
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