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510(k) Data Aggregation

    K Number
    K231216
    Device Name
    POTENZA
    Manufacturer
    Jeisys Medical Inc.
    Date Cleared
    2024-12-10

    (592 days)

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

    Jeisys Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The POTENZA generates radiofrequency (RF) energy by means of high RF at IMHz or 2MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The POTENZA has two operating modes: monopolar mode and bipolar mode.
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    K Number
    K231287
    Device Name
    POTENZA
    Manufacturer
    Jeisys Medical Inc.
    Date Cleared
    2024-11-05

    (551 days)

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

    Jeisys Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The POTENZA is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The POTENZA generates radiofrequency (RF) energy by means of high RF at 1MHz or 2MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The POTENZA has two operating modes: monopolar mode and bipolar mode. The NEW POTENZA consists of the following components: Electrosurgical Unit - Main body, handpieces (Predicate Device have Motor, AC handpieces), electrode tips for the handpiece – Add three non-invasive tips connect to S handpiece, Neutral electrode pad and neutral electrode pad cable, cleared under K201685, Handpiece stand, Foot switch, Power cord.
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    K Number
    K230663
    Device Name
    Density
    Manufacturer
    Jeisys Medical Inc.
    Date Cleared
    2023-08-14

    (157 days)

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

    Jeisys Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DENSITY indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    Device Description
    The DENSITY generates radiofrequency (RF) energy by means of high RF at 6.78MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. In detail, the main body uses the "reverse thermal gradient" principle to deliver RF energy, and thus, heat is generated and selective coaqulation occurs while cooling the epidermis, resulting in denaturation and contraction of collagen fibers. The DENSITY is an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. The DENSITY consists of the following components: •Electrosurgical Unit - Main body •Handpiece •6 different electrode tips •Neutral electrode pad and neutral electrode pad cable, cleared under K201685 •Foot switch •Power cord
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    K Number
    K183284
    Device Name
    INTRAcel RF Microneedle System
    Manufacturer
    Jeisys Medical Inc.
    Date Cleared
    2020-01-15

    (415 days)

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

    Jeisys Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    INTRAcel RF Microneedle System is indicated for use in dermatological and general surgical procedures for electrocoagulation, hemostasis and the percutaneous fractional treatment of the skin in monopolar and bipolar mode.
    Device Description
    The INTRAcel RF Microneedle System comprises of two primary components; an RF Generator with User Interface Software and a disposable Electrode Insertion Device with an integrated cable.
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    K Number
    K162169
    Device Name
    EdgeOne CO2 Laser
    Manufacturer
    Jeisys Medical Inc.
    Date Cleared
    2016-10-27

    (85 days)

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

    Jeisys Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
    Device Description
    The Jeisys EdgeOne CO2 Laser is comprised of the following major components: 1. The main console unit 2. Delivery handpieces (2 surgical and one fractional) 3. Footswitch. 4. Accessories
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