BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OPHTHALMED LLC

    Reg #: 3004497289 · FEI: 3004497289 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    OPHTHALMED LLC
    Registration Number
    3004497289
    FEI Number
    3004497289
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1050 Northfield Ct Ste 280
    City
    ROSWELL
    State
    GA
    ZIP
    30076
    Country
    US

    Regulatory Submissions

    510(k) Number
    K050807

    Owner / Operator

    Firm Name
    OPHTHALMED LLC
    Operator Number
    9051325
    Address
    1050 NORTHFIELD COURT, SUITE 280
    City
    Roswell
    State
    GA
    Postal Code
    30076
    Country
    US
    Correspondent
    JAY - MANSOUR

    Products

    Device Name Product Code
    Laser, Ophthalmic HQF
    Powered Laser Surgical Instrument GEX
    Photocoagulator And Accessories HQB

    Proprietary Names

    A4xx010 (20g laser/asp probe) A6xxx10 (20g laser/illum/asp probe) A92x013 (23g laser/asp probe) B62xx13 (23g laser/illum/asp probe) A5xxx0x (20g, 23g and 25g laser/illum probe) LF20 and A2xx000 (20g laser probe) LF25 and A3xx000 (25g laser probe) A8xx000 (23g laser probe) Ax0x000 (bending laser probes, 20g/23g/25g)

    Establishment Types

    Manufacture Medical Device