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    K Number
    K243176
    Device Name
    BLESSING System
    Manufacturer
    Cellah Medical Co., Ltd.
    Date Cleared
    2025-05-16

    (228 days)

    Product Code
    GEI,OUH
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K201685
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cellah Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The BLESSING System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

    Device Description

    The device is used for coagulation through high-frequency current and consists of a main body, three types of handpieces, a handpiece stand, an electrode, a neutral (counter) electrode, a counter electrode connection cable, a foot switch, and a power cord, all controlled by software. It works on the principle that skin tissue coagulates due to heat generated by the load or contact resistance when high-frequency (RF) energy is applied to the tissue.

    AI/ML Overview

    This FDA Clearance Letter for the BLESSING System (K243176) does not describe a study involving AI or diagnostic performance, but rather concerns an electrosurgical device. Therefore, it does not provide the information requested regarding acceptance criteria and a study proving a device meets those criteria for AI-assisted diagnostic performance.

    The document discusses:

    • The device: BLESSING System, an electrosurgical cutting and coagulation device.
    • Its intended use: Dermatologic and general surgical procedures for electrocoagulation and hemostasis.
    • Predicate device: POTENZA (K201685).
    • Substantial Equivalence: A comparison of the BLESSING System with its predicate device, highlighting minor differences in specifications (e.g., max output power, voltage output, weight, dimension, input voltage) but arguing these differences do not affect safety and effectiveness.
    • Performance Tests (Non-clinical): This section details the engineering and safety tests conducted on the device, such as EMC, electrical safety, usability, biocompatibility (cytotoxicity, skin sensitization, irritation, systemic toxicity, pyrogen, hemolysis), cleaning validation, packaging validation, sterilization validation, and software validation. These are standard tests for medical devices to ensure their safe and effective operation, not diagnostic performance.

    Therefore, I cannot provide the requested information about acceptance criteria for diagnostic performance or an AI study from this document, as it is completely irrelevant to the context of AI or diagnostic imaging.

    If you have a document about an AI-powered diagnostic device, please provide that, and I would be happy to help.

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