DEVICE: VisuMax (04049471095036)

Device Identifier (DI) Information

VisuMax
VisuMax
In Commercial Distribution

Carl Zeiss Meditec AG
04049471095036
GS1

1
314594680 *Terms of Use
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.
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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
HNO Keratome, Ac-Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
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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 Record Status

75281e57-f96d-4de8-a7ba-6cb088f340b5
November 23, 2018
3
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
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Yes
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Customer Contact

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No Customer Contact currently defined
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