BEUDAMED
    FDA Registration Active 🇨🇳 China

    Diode Laser Hair Removal System for Medical Use Milestone Smart-M

    Reg #: 3012125201 · FEI: 3012125201 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SANHE LASERCONN TECH CO., LTD.
    Registration Number
    3012125201
    FEI Number
    3012125201
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    X03-A Building, Baishijingu Industry Park, Yanjiao
    City
    Langfang Hebei
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K222800

    Owner / Operator

    Firm Name
    Sanhe Laserconn Tech Co., Ltd.
    Operator Number
    10079395
    Address
    X03-A Building, Baishijingu Industry Park, Yanjiao
    City
    Langfang
    State
    Hebei
    Postal Code
    065201
    Country
    CN
    Correspondent
    Wang Gary

    US Agent

    Business Name
    Casus Consulting LLC
    Contact Name
    Ann Marie Boullie
    Address
    3800 N Lamar Blvd Ste 200
    City
    Austin
    State
    TX
    ZIP
    78756
    Country
    US
    Email
    [email protected]
    Phone
    972 5326357

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    Diode Laser Hair Removal System for Medical Use Milestone Smart-M Diode Laser Hair Removal System for Medical Use Milestone Standard-A

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198