BEUDAMED
    FDA Registration Active 🇨🇳 China

    BEIJING WINKONLASER TECHNOLOGY LIMITED

    Reg #: 3015452693 · FEI: 3015452693 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    19
    Establishment Types
    4
    Classifications
    13

    Registration Details

    Registration Name
    BEIJING WINKONLASER TECHNOLOGY LIMITED
    Registration Number
    3015452693
    FEI Number
    3015452693
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    No.28,Hegezhuang,Xiji Town,Tongzhou Dist.
    City
    Beijing
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221246

    Owner / Operator

    Firm Name
    Beijing Winkonlaser Technology Limited
    Operator Number
    10086148
    Address
    No.28,Hegezhuang,Xiji Town,Tongzhou Dist.
    City
    Beijing
    State
    CN-BJ
    Postal Code
    101108
    Country
    CN
    Correspondent
    Jingya Zhang

    Products

    Device Name Product Code
    Brush, Dermabrasion, Powered GFE
    Gas, Laser Generating NXF
    Powered Microneedle Device QAI
    Light Based Over-The-Counter Hair Removal OHT
    Powered Laser Surgical Instrument GEX
    Laser, Cellulite Appearance OYW
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue PZC
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Massager, Vacuum, Radio Frequency Induced Heat PBX
    Stimulator, Muscle, Powered IPF
    Powered Surgical Instrument For Improvement In The Appearance Of Cellulite OUP
    Device, Skin Potential Measurement HCJ

    Proprietary Names

    Aqua Facial Hydrogen Oxygen Bubble System CO2 Fractional Laser System Microneedle Fractional RF System IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) Diode Laser Hair Removal System falcon 4 pro Diode Laser Hair Removal System laser, cellulite appearance - Cryolipolysis Beauty System Elight System; IPL; SHR Long Pulse Alexandrite Laser System High Intensity Focus Ultrasound (HIFU) System CO2 Fractional Laser ND:yag Q-Switch Laser System; Picosecond System Radio frequency and vacuum machine ELECTRONIC MUSCLE STIMULATOR Long Pulse Nd: YAG Laser System Nd:YAG Laser Picosecond Laser System IPL DPL SHR Elight Therapy Machine HIFEM Beauty System Skin Analyzer System

    Establishment Types

    Manufacture Medical Device Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device for Another Party (Contract Manufacturer)