BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    MR Q SLT

    DI: 03830074980024 · Model: MR Q SLT s, MR Q SLT c · Meridian Medical d.o.o.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    MR Q SLT
    Primary DI
    03830074980024
    Version / Model
    MR Q SLT s, MR Q SLT c
    Catalog Number
    780015, 780016
    Company Name
    Meridian Medical d.o.o.
    Labeler DUNS
    644472151
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-10-20
    Public Version
    2
    Public Version Date
    2025-11-24
    Public Version Status
    Update
    Public Device Record Key
    160b1209-8ab6-4537-8da7-5545abc74555

    Device Description

    The MR Q SLT is a Q-switched Nd:YAG ophthalmic laser system designed for selective laser trabeculoplasty (SLT) procedures in seated patients. It emits laser pulses at a wavelength of 532 nm with a pulse duration of approximately 3 to 4 nanoseconds. The energy output is adjustable between 0.2 and 2.0 mJ, optimized for targeting pigmented trabecular meshwork cells while minimizing thermal damage to surrounding tissue. The system features dual red diode aiming beams (635 nm) for precise targeting and a super Gaussian beam profile for uniform energy distribution. It includes Haag-Streit-style binoculars with tilt adjustment (0–210 degrees), joystick control, and an optional footswitch. The integrated CSO 9800 LED slit lamp (Zeiss type) provides magnification from 6x to 40x. The MR Q SLT is air-cooled and includes safety features such as keypad access and audible alarms. It is compliant with IEC 60601-1, EN 60601-1-2, and MDD 93/42/EEC standards. Indications for use include selective laser trabeculoplasty for the treatment of open-angle glaucoma. The MR Q SLT is designed to deliver precise and effective laser therapy in a compact and ergonomic format.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    Yes
    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
    HQF Laser, Ophthalmic

    GMDN Terms

    Code Name
    62197 Ophthalmic solid-state laser system

    Identifiers

    Type ID
    Primary 03830074980024