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    VisuMax

    DI: 04049471095036 · Model: VisuMax · Carl Zeiss Meditec AG
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VisuMax
    Primary DI
    04049471095036
    Version / Model
    VisuMax
    Company Name
    Carl Zeiss Meditec AG
    Labeler DUNS
    314594680
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2018-11-23
    Public Version Status
    Update
    Public Device Record Key
    75281e57-f96d-4de8-a7ba-6cb088f340b5

    Device Description

    The VisuMax laser keratome is a femtosecond laser. It generates a beam of ultra-short laser pulses which are guided through the aperture in the treatment objective . The optical system focuses the laser beam into the corneal tissue. The VisuMax femtosecond laser is indicated for use in ophthalmic surgery for the creation of corneal incisions in patients undergoing the following treatments: • In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea • In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea • In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty • In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting • Surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments. Additionally under class III: The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia with or without astigmatism • for spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters, • for cylinder from -0.75 diopters through -3.00 diopters, • when refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of ≤ 0.50 D in magnitude.

    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
    No
    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
    OTL Femtosecond Laser System For Refractive Correction
    HNO Keratome, Ac-Powered

    GMDN Terms

    Code Name
    57995 Femtosecond ophthalmic solid-state laser system

    Identifiers

    Type ID
    Primary 04049471095036

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Weight (basic unit) 470 kg
    Device Size Text, specify Weight (PSS): 250 kg
    Device Size Text, specify Weight (platform): 150 kg
    Device Size Text, specify L x W: 4.00 m x 3.70 m

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    Local altitude max. 2000 m
    Type
    Storage Environment Humidity
    Temperature Range
    30 – 70 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    1 – 40 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    30 – 70 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    18 – 25 Degrees Celsius