BEUDAMED
    FDA Registration Active 🇨🇳 China

    iHelmet Hair Growth System, model: LTD 88Lite

    Reg #: 3013553501 · FEI: 3013553501 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    SLINPH TECHNOLOGIES CO., LTD
    Registration Number
    3013553501
    FEI Number
    3013553501
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room201 and 202, Building B54, Jinke Yida Science & Technology City, No. 77 South Section of Dongliu Road, Changsha Economic and Technological Development Zone
    City
    Changsha Hunan
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K190467

    Owner / Operator

    Firm Name
    Slinph Technologies Co., LTD
    Operator Number
    10054743
    Address
    Room201 and 202, Building B54, Jinke Yida Science & Technology City, No. 77 South Section of Dongliu Road, Changsha Economic and Technological Development Zone
    City
    Changsha
    State
    Hunan
    Postal Code
    410100
    Country
    CN
    Correspondent
    KEVIN ZOU

    US Agent

    Business Name
    SHARE INFO INC.
    Contact Name
    Clare Ho
    Address
    3557 158th St Flushing, NY
    City
    Flushing
    State
    NY
    ZIP
    11358
    Country
    US
    Email
    [email protected]
    Phone
    929 4102964

    Products

    Device Name Product Code
    Laser, Comb, Hair OAP

    Proprietary Names

    iHelmet Hair Growth System, model: LTD 88Lite iHelmet Hair Growth System, model: LTD 160Pro iHelmet Hair Growth System, model: LTD 36Air

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device Complaint File Establishment per 21 CFR 820.198