BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ACCUTOME, INC.

    Reg #: 2521877 · FEI: 2521877 · Expires 2026
    View on FDA
    Products
    50
    Proprietary Names
    13
    Establishment Types
    5
    Classifications
    50

    Registration Details

    Registration Name
    ACCUTOME, INC.
    Registration Number
    2521877
    FEI Number
    2521877
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3222 Phoenixville Pike
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140450

    Owner / Operator

    Firm Name
    ACCUTOME, INC.
    Operator Number
    2521877
    Address
    3222 Phoenixville Pike, --
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US
    Correspondent
    Claudia Hill

    Products

    Device Name Product Code
    Camera, Ophthalmic, Ac-Powered HKI
    Specula, Ophthalmic HNC
    Tonometer, Manual HKY
    Biomicroscope, Slit-Lamp, Ac-Powered HJO
    Probe HXB
    Forceps, Ophthalmic HNR
    Chart, Visual Acuity HOX
    Spoon, Ophthalmic HNB
    Adaptometer (Biophotometer) HJW
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Ophthalmoscope, Battery-Powered HLJ
    Ophthalmoscope, Ac-Powered HLI
    Eye Tray OJK
    Hook, Ophthalmic HNQ
    Tonometer, Ac-Powered HKX
    Transducer, Ultrasonic, Diagnostic ITX
    Camera, Ophthalmic, General-Use PJZ
    Gauge, Measuring JYJ
    Cannula, Ophthalmic HMX
    Retinoscope, Ac-Powered HKL
    Instrument, Microsurgical GZX
    Caliper, Ophthalmic HOE
    Unit, Cryophthalmic, Ac-Powered HRN
    Perimeter, Manual HON
    Scissors, Ophthalmic HNF
    Suture, Nonabsorbable, Synthetic, Polyamide GAR
    Holder, Needle, Gastroenterologic FHQ
    Spatula, Ophthalmic HND
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Needle, Suturing, Reusable GDL
    Depressor, Orbital HNX
    Dilator, Lachrymal HNW
    Tray, Surgical, Instrument FSM
    Transilluminator, Ac-Powered HJM
    Ring, Ophthalmic (Flieringa) HNH
    Shell, Scleral HQT
    Topographer, Corneal, Ac-Powered MMQ
    Knife, Ophthalmic HNN
    Knife, Surgical EMF
    Suture, Absorbable, Synthetic, Polyglycolic Acid GAM
    Punch, Corneo-Scleral HNJ
    Powered Laser Surgical Instrument GEX
    Telescope, Spectacle, Low-Vision HKK
    Marker, Ocular HMR
    Curette, Ophthalmic HNZ
    Suture, Nonabsorbable, Silk GAP
    Microscope, Operating & Accessories, Ac-Powered, Ophthalmic HRM
    Unit, Electrolysis, Battery-Powered, Ophthalmic HPY
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Stimulator, Photic, Evoked Response GWE

    Proprietary Names

    Stimuli CVT Roland Darkadoptometer PDT Kit Generic GENERIC OPHTHALMIC RING IMMERSION SHELL DIAMOND OPHTHLMIC KNIFE Punch, Kelly OPHTHALMIC MARKER OPHTHAMIC CURETTE UBM Plus UBM Plus Guarded

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility