BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PiXel8

    Reg #: 3031944951 · FEI: 3031944951 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    ROHRER AESTHETICS, INC.
    Registration Number
    3031944951
    FEI Number
    3031944951
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    121 Citation Ct
    City
    Homewood
    State
    AL
    ZIP
    35209
    Country
    US

    Regulatory Submissions

    510(k) Number
    K180654

    Owner / Operator

    Firm Name
    Rohrer Aesthetics, Inc.
    Operator Number
    10091003
    Address
    121 Citation Court
    City
    Homewood
    State
    AL
    Postal Code
    35209
    Country
    US
    Correspondent
    Sandra Hansen

    Products

    Device Name Product Code
    Skin Resurfacing Rf Applicator OUH
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    PiXel8

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198