BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SPECLIPSE, INC.

    Reg #: 3013697074 · FEI: 3013697074 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SPECLIPSE, INC.
    Registration Number
    3013697074
    FEI Number
    3013697074
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #501, #502, #503, #504, #505, 232 Sandan-ro, Danwon-gu
    City
    Ansan-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K261214

    Owner / Operator

    Firm Name
    SPECLIPSE, Inc.
    Operator Number
    10094634
    Address
    #501, #502, #503, #504, #505, 232 Sandan-ro, Danwon-gu
    City
    Ansan-si
    State
    Gyeonggi
    Postal Code
    15433
    Country
    KR
    Correspondent
    Park Myung Seo

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    PICOFY PICO-K BELLUS-Q QMODE

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device