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510(k) Data Aggregation

    K Number
    K254290

    Validate with FDA (Live)

    Device Name
    ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)
    Manufacturer
    Shenzhen Peninsula Medical Group
    Date Cleared
    2026-01-30

    (30 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K241832
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ZenTite is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The ZenTite is used for the relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation.

    Device Description

    The ZenTite system consists of a host, a footswitch, a power cord, handpieces (optional) and electrodes (optional). The treatment handle includes a handpiece, a sterilized or not sterilized electrode. There are three types of handpieces and each type is connected with one selected electrode. They are MicroRF handpiece connected with MicroRF series electrodes (MicroRF 49, MicroRF 25, MicroRF 9N, MicroRF 25N), Artist handpiece connected with Artist series electrodes (Artist D2.0, Artist D3.5, Artist D4.5, Artist D6.0) and Pure+ handpiece connected with Pure+ B1 electrode.

    AI/ML Overview

    N/A

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