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510(k) Data Aggregation

    K Number
    K230342
    Device Name
    Phototherapy System (OL-PDT950)
    Date Cleared
    2023-08-16

    (189 days)

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

    Shanghai Omni Laser Skinology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Phototherapy System use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The blue light (469mm wavelength) indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The red light (633nm wavelength) indicated to treatment of superficial, benign vascular, and pigmented lesions. The infrared light (835nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
    Device Description
    The Phototherapy System OL-PDT950 is a vertical device which uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±15nm), in the blue light regions of the light spectrum (469±15nm) and infrared light region of light spectrum (835±15nm). Five sets of LEDs panels are available for the device.
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    K Number
    K223778
    Device Name
    Diode Laser Hair Removal System (RD-SLD600)
    Date Cleared
    2023-03-31

    (105 days)

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

    Shanghai Omni Laser Skinology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Diode Laser Hair Removal System (RD-SLD600) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term. stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
    Device Description
    The proposed device, Diode Laser Hair Removal System (RD-SLD600) is a professional platform, it is intended for the removal of unwanted hair and to effect stable, long-term hair reduction on all skin types (Fitzpatrick skin type I-VI). The complete system consists of its console, module and a footswitch. The module is pressed against the patient's skin and a light pulse is delivered when the emitted button or the footswitch are activated. The crystal contact surface is cooled by the RD-SLD600's cooling system. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system's microcontroller through and LCD touch-screen.
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    K Number
    K220214
    Device Name
    Painless IPL System - KDT750
    Date Cleared
    2023-02-18

    (388 days)

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

    Shanghai Omni Laser Skinology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IPL System - KDT750 is intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Indications for use for IPL System with 515-980nm IPL Handpiece (SR Handpiece). - · Benign pigmented epidermal and cutaneous lesions including warts, melasma, epithelides (freckles) and lentigines. - · Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, rosacea, erythema of rosacea and poikiloderma of Civatte. - · For use on skin types(I-V) Indications for use for IPL System with 640-950nm IPL Handpiece (HR Handpiece). - · The removal of unwanted hair to effect stable long-term or permanent hair reduction. - · For use on Fitzpatrick skin types (I-V) * Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
    Device Description
    The IPL System - KDT750 is a multi-wavelength non-invasive system for IPL skin treatments, treatment of vascular and pigmented lesions, and hair removal using two wavelength ranges: 530-950nm and 640-950nm. The IPL System consists of a system console, electronics and software, cooling system, and two hand pieces with different wavelength.
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