BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HIRONIC CO., LTD.

    Reg #: 3014980461 · FEI: 3014980461 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    HIRONIC CO., LTD.
    Registration Number
    3014980461
    FEI Number
    3014980461
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    19F, U-TOWER, 767, Sinsu-ro, Suji-gu
    City
    Yongin-Si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K251334

    Owner / Operator

    Firm Name
    Hironic Co., Ltd.
    Operator Number
    10058937
    Address
    19F, U-TOWER, 767, Sinsu-ro, Suji-gu
    City
    Yongin-si
    State
    Gyeonggi
    Postal Code
    16827
    Country
    KR
    Correspondent
    Jinu Lee

    US Agent

    Business Name
    LK Consulting Group USA, Inc.
    Contact Name
    Priscilla Chung
    Address
    2552 Walnut Ave Ste 230
    City
    Tustin
    State
    CA
    ZIP
    92780
    Country
    US
    Email
    [email protected]
    Phone
    714 9225276

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Powered Laser Surgical Instrument GEX
    Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat IMI
    Laser For Disruption Of Adipocyte Cells For Aesthetic Use PKT
    Massager, Therapeutic, Electric ISA

    Proprietary Names

    RF Micro Needle Tip (Model: RMT-N25) RM Handpiece PS Tip PS Handpiece RF Micro Needle Tip (Model: RMT-I25) NEW DOUBLO 2 RF Micro Needle Tip (Model: RMT-N49) RM(B) Handpiece RF Micro Needle Tip (Model: RMT-I49) SYNERJET PRO, InPhiuse, WOWJET (Model Name: SP-1002) SILKRO PICOHI Plasonic RC Handpiece GP Cable RN Handpiece A-FIT RF Needle Tip (Model: A-FIT RN 1.8) A-FIT RF Needle Tip (Model: A-FIT RN 1.5) RF Venus Stick RV Handpiece Ground Pad A-FIT RF Needle Tip (Model: A-FIT RN 1.2) SLIMUS

    Establishment Types

    Manufacture Medical Device