BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Dermalux

    DI: 05060762460028 · Model: Flex MD · AESTHETIC TECHNOLOGY LTD
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Dermalux
    Primary DI
    05060762460028
    Version / Model
    Flex MD
    Catalog Number
    1000053
    Company Name
    AESTHETIC TECHNOLOGY LTD
    Labeler DUNS
    218753736
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-09-02
    Public Version
    2
    Public Version Date
    2026-02-11
    Public Version Status
    Update
    Public Device Record Key
    876c0ecb-81d8-4c53-8c94-5fc7d245dc30

    Device Description

    The Dermalux® Flex MD is a Medical Device for use on a treatment bed/surface. The device emits specific wavelengths of low level, narrow band light for the treatment of certain cosmetic, dermatological and medical indications. The wavelengths used in the Dermalux® Flex MD system are Blue 415nm, Red 633nm and Near Infrared 830nm.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument
    ILY Lamp, Infrared, Therapeutic Heating

    GMDN Terms

    Code Name
    62202 Blue/red/infrared phototherapy lamp

    Identifiers

    Type ID
    Primary 05060762460028