VISUMAX

GUDID 04049471095111

The VISUMAX 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 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 lower or equal 0.50 D in magnitude.

Carl Zeiss Meditec AG

Femtosecond ophthalmic solid-state laser system

• Primary Device ID: 04049471095111
• NIH Device Record Key: 37292101-bae4-4de9-8e0a-7230f604567a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISUMAX
• Version Model Number: VISUMAX 800 or 09511
• Company DUNS: 314594680
• Company Name: Carl Zeiss Meditec AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Weight: 520 Kilogram
• Device Size Text, specify: 0
• Weight: 520 Kilogram
• Device Size Text, specify: 0
• Weight: 520 Kilogram
• Device Size Text, specify: 0
• Weight: 520 Kilogram
• Device Size Text, specify: 0
• Weight: 520 Kilogram
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 64.4 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 20.671 Inches of Mercury and 31.302 Inches of Mercury
• Storage Environment Atmospheric Pressure: Between 14.765 Inches of Mercury and 31.302 Inches of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 64.4 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 20.671 Inches of Mercury and 31.302 Inches of Mercury
• Storage Environment Atmospheric Pressure: Between 14.765 Inches of Mercury and 31.302 Inches of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 64.4 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 20.671 Inches of Mercury and 31.302 Inches of Mercury
• Storage Environment Atmospheric Pressure: Between 14.765 Inches of Mercury and 31.302 Inches of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 64.4 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 20.671 Inches of Mercury and 31.302 Inches of Mercury
• Storage Environment Atmospheric Pressure: Between 14.765 Inches of Mercury and 31.302 Inches of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 64.4 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 20.671 Inches of Mercury and 31.302 Inches of Mercury
• Storage Environment Atmospheric Pressure: Between 14.765 Inches of Mercury and 31.302 Inches of Mercury
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049471095111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150040

FDA Product Code

• OTL: Femtosecond Laser System For Refractive Correction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-23
• Device Publish Date: 2024-12-13

On-Brand Devices [VISUMAX]

• 04049471095036: The VisuMax laser keratome is a femtosecond laser. It generates a beam of ultra-short laser puls
• 04049471095111: The VISUMAX is a femtosecond laser. It generates a beam of ultra-short laser pulses which are g