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510(k) Data Aggregation

    K Number
    K222555
    Device Name
    reepot Nd; YAG laser system
    Manufacturer
    Ilooda Co., Ltd.
    Date Cleared
    2022-09-23

    (31 days)

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

    Ilooda Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reepot laser system is indicated for the incision, 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, skyblue, green) - Removal of Epidermal Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Treatment of Lentigines - Treatment of Cafe-Au-Lait - Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyper-Pigmentation - Treatment of Becker's Nevi, Freckles and Nevi Spilus
    Device Description
    The reepot Nd;Y AG laser system is comprised of the following major components: - 1) Laser system console - 2) LCD control panel - 3) VSLS handpieces (included camera and LCD display) - 4) Footswitch. - 5) Accessories
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    K Number
    K182355
    Device Name
    Secret RF Smartcure Applicator with electrodes
    Manufacturer
    Ilooda Co., Ltd.
    Date Cleared
    2019-09-06

    (372 days)

    Product Code
    GEI, KCW, ONQ, OUH
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ilooda Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Secret RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
    Device Description
    Secret RF's High Frequency(=Radio Frequency) includes the system main body, a handpices with singleuse micro-needle type electrodes, footswitch and an LCD touch screen control panel. The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip. The Secret RF is consists of ; - 1) Secret RF main unit (FDA cleared K170325) - 2) Bipolar type handpieces with Bipolar type micro-needle electrodes (FDA cleared K170325) - 3) Secret RF Smartcure applicator The Secret RF Smartcure Applicator consists of : - Smartcure handpiece - Monopolar type micro-needle electrodes (MTR-AC-01 , MTR-AC-04, MTR-AC-27G, K3i)
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    K Number
    K173474
    Device Name
    RetiCapture
    Manufacturer
    Ilooda Co., Ltd.
    Date Cleared
    2018-07-27

    (260 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ilooda Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RetiCapture is a digital hand-held (portable) eye-fundus camera used to record digital photographs and video of fundus of the human eye and surrounding area.
    Device Description
    RetiCapture is a hand-held digital ophthalmic camera that together with the optics modules used to capture digital images and video of fundus and surrounding area of the human eye. RetiCapture has an LED light source visible white light and infrared light. Light target LED's are used to eye position fixation during imaging. Image data is stored on the Flash memory card using 5 megapixel CMOS sensor and transferred to the PC by using USB connection. Device has rechargeable battery.
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    K Number
    K173038
    Device Name
    CuRAS Nd:YAG Laser
    Manufacturer
    Ilooda Co., Ltd.
    Date Cleared
    2017-12-01

    (64 days)

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

    Ilooda Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CuRAS Nd; Y AG laser system in indicated for : the incision, 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, skyblue, green) - Removal of Epidermal Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Treatment of Lentigines - Treatment of Cafe-Au-Lait - Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyper-Pigmentation - Treatment of Becker's Nevi, Freckles and Nevi Spilus 1064nm Wavelength: - Tattoo removal: dark ink (black, blue and brown) - Removal of Nevus of Ota - Removal or lightening of unwanted hair with or without adjuvant preparation. - Treatment of Common Nevi - Skin resurfacing procedures for the treatment of acne scars and wrinkle
    Device Description
    The CuRAS Nd;YAG laser system is comprised of the following major components: - 1. The main console unit - 2. Delivery handpieces - 3. Footswitch. - 4. Accessories
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    K Number
    K170325
    Device Name
    SECRET RF
    Manufacturer
    Ilooda Co., Ltd.
    Date Cleared
    2017-06-13

    (131 days)

    Product Code
    GEI, OUH
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ilooda Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SECRET RF is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.
    Device Description
    Secret RF's High Frequency(=Radio Frequency) includes the system main body, a bipolar handpiece(Two type) with disposable micro-needle type electrodes, footswitch and an LCD touch screen control panel. The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip.
    Ask a Question

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