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510(k) Data Aggregation

    K Number
    K232223
    Device Name
    PlaDuo System
    Manufacturer
    ShenB Co Ltd
    Date Cleared
    2023-10-24

    (90 days)

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

    ShenB Co Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Argon handpiece is intended for the removal and destruction of skin lesions and the coagulation of tissue.
    Device Description
    The PlaDuo System is an electro-surgical device for use in dermatological applications. The device utilizes nitrogen and argon gas to be used separately to generate the desired power level to patients. The effect of the device is achieved by heating the outer layer of the skin so that part or all of it becomes non-viable and there is controlled damage to the underlying skin. The PlaDuo system consists of a system console with wells for 2 gas tanks, footswitch, 2 handpieces, and tip with 3 interchangeable guides.
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    K Number
    K230968
    Device Name
    VYBE RF Electrosurgical System
    Manufacturer
    ShenB Co Ltd
    Date Cleared
    2023-07-06

    (92 days)

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

    ShenB Co Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VYBE RF Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment of facial wrinkles for use with Fitzpatrick Skin Type I to Skin Type V when using the 1MHz setting. The 2MHz setting has not been evaluated for use in the percutaneous treatment of facial wrinkles and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The VYBE RF Electrosurgical System is comprised of the following components: - . The system main body, consisting of: - o LCD touch screen control panel - High-frequency generating output section (main P.C.B board or RF Generator) O - Power supply component Switch Mode Power Supply (SMPS) O - The accessories to the device include: - Handpiece with Handpiece Connector O - Disposable micro-needle cartridge (electrode) for insertion into Handpiece o - Foot switch O Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator and hand piece are not disposable. Each disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be re-sterilized.
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    K Number
    K221363
    Device Name
    AF Laser
    Manufacturer
    ShenB Co Ltd
    Date Cleared
    2022-07-20

    (70 days)

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

    ShenB Co Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AF Laser device is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
    Device Description
    The AF Laser is a medical laser used to treat nail fungus (onychomycosis) and promote the growth of healthy nails. The operating mechanism of this device is photochemical reaction that uses two wavelengths -- 635nm and 405nm. The AF laser is a compact, all-in-one device that is intended to be used on the floor and is operated by an intuitive 10.2 inch's wide LCD screen for ease of use. An LCD monitor incorporated into the deck of the device helps the operator check the exact location of treatment area during a procedure.
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    K Number
    K211562
    Device Name
    Virtue RF
    Manufacturer
    ShenB Co Ltd
    Date Cleared
    2021-11-23

    (187 days)

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

    ShenB Co Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Virtue RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Smart RF Handpiece: The Smart RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System for facial wrinkles is intended for use with Skin Types I-V. The Smart RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The with 2MHz functionality is not intended to treat wrinkles. Exact RF Handpiece: The Exact RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Exact RF Handpiece is not intended to treat wrinkles. Deep RF Handpiece: The Deep RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 1MHz functionality is not intended to treat wrinkles. The Deep RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 2MHz functionality is not intended to treat wrinkles. The Deep RF Handpiece with 0.5MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 0.5MHz functionality is not intended to treat wrinkles.
    Device Description
    The VirtueRF device is a radio frequency output device using 0.5MHz, 1MHz & 2Mhz to deliver radio frequency energy to the human body with 3 applicators that attach to the connecting cable. The energy is applied to the human body using sterile disposable needle arrays consisting of 36 needles, 12 needles, o 1 needle. This product consists of main body, SmartRF Bipolar handpiece, DeepRF Bipolar handpiece, ExactRF Monopolar handpiece, connector cable, grounding plate for ExactRF, cooling plate for the DeepRF, foot switch and power cord.
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    K Number
    K193070
    Device Name
    VIVACE Electrosurgical Device
    Manufacturer
    ShenB Co Ltd.
    Date Cleared
    2021-04-26

    (539 days)

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

    ShenB Co Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment of facial wrinkles for use with Fitzpatrick Skin Type I to Skin Type V when using the 1MHz setting. The 2MHz setting has not been evaluated for use in the percutaneous treatment of facial wrinkles and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The VIVACE Electrosurgical System is comprised of the following components: - . The system main body, consisting of: - LCD touch screen control panel O - High-frequency generating output section (main P.C.B board or RF Generator) O - Power supply component Switch Mode Power Supply (SMPS) O - The accessories to the device include: ● - Handpiece with Handpiece Connector o - Disposable micro-needle cartridge (electrode) for insertion into Handpiece O - Foot switch O Radio frequency current (RF energy) is delivered from the RF Generator, through the handpiece and electrode tip into the target tissue. As RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating (causing minor dermal damage) the tissue. The bi-polar RF energy is delivered between independent adjacent electrode pairs (total 36 needle electrode, 6 x 6 array insertion). The RF generator and hand piece are not disposable micro-needle cartridge (electrode) is supplied sterile and is for single patient use only and cannot be re-sterilized.
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    K Number
    K202415
    Device Name
    VirtueRF
    Manufacturer
    ShenB Co Ltd
    Date Cleared
    2021-01-22

    (151 days)

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

    ShenB Co Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VirtueRF Electrosurgical System has separate indications for use for each of its functionalities: 1MHz and 2MHz. 1MHz Indications for use: Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System is intended for use with Skin Types I-V. 2MHz Indications for use: Intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The 2mHz frequency is not intended to treat wrinkles.
    Device Description
    The VirtueRF device is a radio frequency output device using 1MHz & 2Mhz to deliver radio frequency energy to the human body with an applicator attached to the connecting cable. The energy is applied to the human body using a sterile disposable needle array consisting of 36 needles. This product consists of main body, Needle Bipolar RF (Smart RF) handpiece cable, foot switch and power cord.
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    K Number
    K201735
    Device Name
    PlaDuo System
    Manufacturer
    ShenB Co Ltd
    Date Cleared
    2020-12-14

    (172 days)

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

    ShenB Co Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PlaDuo is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The ShenB Co Ltd PlaDuo is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin so that part or all of the epidermis becomes non-viable and there is controlled damage to the underlying dermis. The PlaDuo system consists of a system console, footswitch, handpiece, and tip with 3 interchangeable guides.
    Ask a Question

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