BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SculpSure laser assembly

    DI: 00841494100032 · Model: 100-7026-010 · Cynosure, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SculpSure laser assembly
    Primary DI
    00841494100032
    Version / Model
    100-7026-010
    Company Name
    Cynosure, LLC
    Labeler DUNS
    780318028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-07-26
    Public Version
    3
    Public Version Date
    2023-01-11
    Public Version Status
    Update
    Public Device Record Key
    28c48f71-822c-49b8-b3d6-6b93c0f86f44

    Device Description

    SculpSure laser assembly

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    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
    PKT Laser for disruption of adipocyte cells for aesthetic use

    GMDN Terms

    Code Name
    58252 Low-intensity laser fat liquefaction system

    Identifiers

    Type ID
    Primary 00841494100032