BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Merilas

    DI: 03830074980048 · Model: Merilas 532 alpha, Merilas 532 / 577 / 810 shortpulse · Meridian Medical d.o.o.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Merilas
    Primary DI
    03830074980048
    Version / Model
    Merilas 532 alpha, Merilas 532 / 577 / 810 shortpulse
    Catalog Number
    100491, 100557, 100555, 100580
    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
    e9d1f339-de28-4114-b9b2-3ab32dd8ec4d

    Device Description

    Merilas ophthalmic laser systems are solid-state, slit lamp-mounted devices designed for photocoagulation and other ophthalmic laser treatments. All models feature a compact design, air-cooled operation, and user-friendly interface with adjustable parameters for power, pulse duration, and repetition rate. Each system includes a slit lamp adapter, aiming beam, and ergonomic controls for precise treatment delivery. The product family includes four wavelength-specific models: Merilas 532 alpha: Continuous-wave laser emitting at 532 nm, used for retinal photocoagulation procedures such as panretinal and focal treatments. Merilas 532 shortpulse: Short-pulse laser at 532 nm, designed for subthreshold retinal therapy to reduce thermal damage while maintaining therapeutic effect. Merilas 577 shortpulse: Short-pulse laser at 577 nm, optimized for treating macular edema and central serous retinopathy with reduced light scattering and selective absorption. Merilas 810 shortpulse: Infrared short-pulse laser at 810 nm, intended for transscleral cyclophotocoagulation and other glaucoma-related procedures requiring deeper tissue penetration. All Merilas systems are compliant with IEC 60601-1, EN 60601-1-2, and applicable medical device directives. They are intended for use by trained ophthalmic professionals in clinical environments.

    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 03830074980048