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510(k) Data Aggregation

    K Number
    K250341

    Validate with FDA (Live)

    Device Name
    Sensilift Pro (ST300XXYYZZZ)
    Manufacturer
    El Global Trade, Ltd.
    Date Cleared
    2026-01-06

    (334 days)

    Product Code
    PAY
    Regulation Number
    878.4420
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    22 - 120
    Reference & Predicate Devices
    K170499,K220322
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Sensilift Pro is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults who have Fitzpatrick Skin Types I IV.

    Device Description

    The Sensilift Pro device is an OTC, home-use hand-held device generating radiofrequency (RF) energy that is emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of:

    • User Interface
    • Programmable logic controller (PLC, microcontroller) embedded in PCBA
    • RF power module
    • Power Supply
    • RF electrodes

    The PLC (on the PCBA) is a specially configured software that, combined with hardware circuits, provides the operational and safety functions of the system. The RF power module provides RF energy to the active tip electrodes, producing a signal of 1MHz frequency (power limited by hardware). This device is supplied non-sterile.

    Technical specifications:

    • Maximal power output: 6 ±1 Watt.
    • Frequency: 1±0.05 MHz
    • Maximal temperature allowed: 40 ± 0.5°C.
    AI/ML Overview

    N/A

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