Duns Number:314594680
Device Description: The VisuMax laser keratome is a femtosecond laser. It generates a beam of ultra-short lase The VisuMax laser keratome is a femtosecond laser. It generates a beam of ultra-short laser pulses whichare 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 incisionlenticule extraction (SMILE) for the reduction or elimination ofmyopia 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.
Catalog Number
-
Brand Name
VisuMax
Version/Model Number
VisuMax
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HNO
Product Code Name
Keratome, Ac-Powered
Public Device Record Key
75281e57-f96d-4de8-a7ba-6cb088f340b5
Public Version Date
November 23, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 14 |
2 | A medical device with a moderate to high risk that requires special controls. | 86 |
3 | A medical device with high risk that requires premarket approval | 1 |