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510(k) Data Aggregation

    K Number
    K241642
    Device Name
    Diode Laser Hair Removal System (MBT-Diode Laser)
    Manufacturer
    Beijing Mega Beauty Technology Co.,Ltd.
    Date Cleared
    2024-08-02

    (56 days)

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

    Beijing Mega Beauty Technology Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diode Laser Hair Removal System (Model: MBT-Diode Laser) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term. stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
    Device Description
    Diode Laser Hair Removal System (Model: MBT-Diode Laser) is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). The Dermatological Diode Laser Systems utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via laser handle. The emission laser is activated by footswitch or handle button. The Diode Laser Hair Removal System consists of the following major components - The main console unit that incorporates the main CPU board, power supply modules, laser power supply, laser device, cooling system and switching module - Handpiece - Footswitch
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    K Number
    K170281
    Device Name
    MSA100BT Peak Flow Meter
    Manufacturer
    Beijing M&B Electronic Instruments Co., Ltd.
    Date Cleared
    2017-10-06

    (249 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing M&B Electronic Instruments Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV 1 (Forced Expiratory Volume in one second) for patient home use. The device is designed for pediatric to adult patients. The device is intended for monitoring respiratory conditions such as asthma.
    Device Description
    MSA100BT Peak Flow Meter is a hand-held pulmonary function measuring medical device that measures patient's maximum possible exhalation which is called peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1). The accuracy meets American Thoracic Society (ATS) Standard 2005 Revision. The MSA100BT is designed for pediatric to adult patients for home use and for single user, and is intended for monitoring respiratory conditions such as asthma. The MSA100BT has an automatic memory of 250 recordings and can connect to cell phone by Bluetooth. Patients can transfer the records to phone via BLE4.0, then using app to help save and track long term. The MSA100BT is capable of measuring PEF from 50 to 900 L/min and FEV1 from 0.01 to 9.99 L. Its measuring accuracy is ± 20 L/min or ± 10% of the reading for PEF, and ± 0.050 L or ± 3% of the reading for FEV1. The MSA100BT is composed of main unit, turbine sensor, and mouth piece. After each use, the mouthpiece and turbine of the device should be cleaned by soap solution and water within 30 minutes.
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    K Number
    K133975
    Device Name
    MSA100 PEAK FLOW METER
    Manufacturer
    BEIJING M&B ELECTRONIC INSTRUMENTS, CO., LTD
    Date Cleared
    2014-10-03

    (281 days)

    Product Code
    BZH
    Regulation Number
    868.1860
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEIJING M&B ELECTRONIC INSTRUMENTS, CO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for monitoring PEF (Peak Expired Flow Rate) and FEV 1 (Forced Expiratory Volume in one second) for patient home use. The device is designed for pediatic to adult patients. The device is intended for monitoring respiratory conditions such as asthma.
    Device Description
    The MSA100 Peak Flow Meter is a medical device that measures patient's maximum possible exhalation which is called "peak flow" (referred to in medical terms as PEF-Peak Expiratory Flow) and "forced expiratory volume" (commonly known as FEV1) in one second. Regular monitoring of the peak flow is useful for monitoring diseases of the airways such as asthma, C.O.P.D, or chronic bronchitis, is usually used for patient home use.
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