BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Waterlase Laser System Turbo Handpiece

    DI: 00647529002285 · Model: 6201126 · Biolase, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Waterlase Laser System Turbo Handpiece
    Primary DI
    00647529002285
    Version / Model
    6201126
    Catalog Number
    6201126
    Company Name
    Biolase, Inc.
    Labeler DUNS
    152165700
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-15
    Public Version
    5
    Public Version Date
    2023-06-12
    Public Version Status
    Update
    Public Device Record Key
    38a21256-17c7-4dbd-b1c1-b7a35eebdf47

    Device Description

    A reusable handpiece intended for use with Waterlase laser systems.

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Moist Heat or Steam Sterilization

    Product Codes

    Code Name
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    47880 Dental solid-state laser system

    Identifiers

    Type ID
    Primary 00647529002285

    Customer Contacts

    Phone
    1-800-321-6717
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K090181 000