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510(k) Data Aggregation

    K Number
    K233374
    Device Name
    Secret Pro
    Manufacturer
    ILOODA Co., Ltd
    Date Cleared
    2023-12-14

    (73 days)

    Product Code
    GEI, GEX, 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
    CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. HF electrosurgical Part : The Secret Pro is intended for use in dermatologic and general surgical procedures for electro coaqulation and hemostasis Secret RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro coagulation and hemostasis
    Device Description
    Not Found
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    K Number
    K212561
    Device Name
    MTX-C1
    Manufacturer
    ILOODA Co., Ltd
    Date Cleared
    2022-09-27

    (410 days)

    Product Code
    GEI, PBX
    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
    The MTX-C1 is intended for the following medical condition; using three types of handpieces for delivery of non-thermal RF combined with massage: - · Relief of minor muscle aches and pain, relief of muscle spasm - Temporary improvement of local blood circulation - · Temporary reduction in the appearance of cellulite
    Device Description
    The MTX-C1 main unit is a RF(Radio-frequency) energy generator employed for a variety of aesthetic applications. The Main unit output is set and monitored via touchscreen and controlled by a footswitch. The main unit can be used with 3 different types of handpieces for treatment. The system consists of ; 1) Main unit 2) 3 type treatment handpiece 3) Footswitch - 4) Touch screen(User interface) The three treatment handpieces differ in size and configuration and are indicated for the treatment of various size areas. The operator can adjust treatment parameters such as the power level and treatment time from the user interface on the Main Unit. The handpiece is applied with a rubbing/massaging technique and the applicator should be moved continuously on the skin.
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    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
    K211000
    Device Name
    ACUTRON
    Manufacturer
    ILOODA Co., Ltd
    Date Cleared
    2022-06-09

    (433 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
    ACUTRON is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
    Device Description
    ACUTRON is High Frequency(=Radio Frequency, RF) includes the system main body, a handpieces with single-use micro-needle type electrodes, footswitch and an LCD touch screen control panel. The RF 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 RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the ACUTRON creates heat within the target dermal tissue via micro-needles inserted from the tip. The ACUTRON is consists of ; 1) Main unit 2) Smartcure handpiece(FDA cleared K182355) 3) Monopolar type micro-needle electrodes(FDA cleared K182355)
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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.
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    K Number
    K160312
    Device Name
    FRAXIS DUO
    Manufacturer
    ILOODA CO., LTD
    Date Cleared
    2016-10-28

    (266 days)

    Product Code
    GEX, GEI, OUH
    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
    - CO2 LASER Part: Fractional mode is indicated only for ablative skin resurfacing. Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. - HF electrosurgical Part : The FRAXIS DUO is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
    Device Description
    FRAXIS DUO is a combination of two separate systems: CO2 laser and HF electrosurgical system. The Laser and High Frequency(=Radio frequency) can not be used simultaneously. FRAXIS DUO's CO2 laser includes the system main body, different handpieces(Fractional type, Non-fractional type), footswitch and an LCD Touch screen control panel. FRAXIS DUO's CO2 laser utilize a CO2 RF tube to generate a laser beam with a wavelength of 10,600nm and use different handpiece(Fractional type, Non-fractional type) for different indications for use. The physician can optimize the effect for different applications by controlling the power of the laser pulse and using a different handpiece. The laser are supplied with different handpieces depending upon the device configuration. FRAXIS DUO's High Frequency(=Radio Frequency) includes the system main body, a Bipolar handpiece equipped with disposable micro-needle electrodes, footswitch and an LCD touch screen control panel. The HF energy is delivered using disposable micro-needle electrodes.
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    K Number
    K151232
    Device Name
    VIKINI Diode Laser System
    Manufacturer
    ILOODA CO., LTD
    Date Cleared
    2015-08-06

    (90 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 VIKINI DIODE LASER SYSTEM is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.
    Device Description
    Not Found
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