DEVICE: VisuMax (04049471095036)

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Device Identifier (DI) Information

VisuMax
VisuMax

Carl Zeiss Meditec AG
04049471095036
GS1
1
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 laser keratome is indicated for the following: • 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 Additionally it's indicated for the use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia ≥ -1.00 D to ≤ -8.00 D, with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of ≤ 0.50 D MRSE.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Femtosecond ophthalmic solid-state laser system A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for ocular resections and incisions (cataract incisions, arcuate corneal/scleral cuts/tunnels, anterior capsulotomy, phacofragmentations, corneal flaps, lamellar/perforating keratoplasty). The system includes a beam delivery device, imaging device, computer, software and controls; it cuts by micro-photodisruption of tissue created by focused ultra-short [femtosecond (FS)] pulses; it does not include fundus imaging technology and the therapeutic laser is not frequency-doubled.
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FDA Product Code

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Product Code Product Code Name
HQF Laser, Ophthalmic
OTL Femtosecond Laser System For Refractive Correction
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Local altitude max. 2000 m
Storage Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Storage Environment Temperature: between 1 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Handling Environment Temperature: between 18 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type 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
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Device Status

In Commercial Distribution
September 23, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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