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VisuMax

FDA UDI

Class II (US FDA UDI)

by Carl Zeiss Meditec AG

Identity

Trade Name
VisuMax FDA UDI
Generic Name
Femtosecond ophthalmic solid-state laser system FDA UDI
Device Name
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 lower or equal 0.50 D in magnitude. FDA UDI
Model / Reference
VisuMax FDA UDI
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 lower or equal 0.50 D in magnitude. FDA UDI

Identifiers

Primary DI / UDI-DI
04049471095036 FDA UDI
FDA Product Code
HQF FDA UDI
OTL FDA UDI
HNO FDA UDI
GMDN Term
Femtosecond ophthalmic solid-state laser system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4390 FDA UDI
886.4370 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Femtosecond ophthalmic solid-state laser system

VisuMax by Carl Zeiss Meditec AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femtosecond ophthalmic solid-state laser system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carl Zeiss Meditec AG

Sources (1)

  • FDA UDI 75281e57-f96d-4de8-a7ba-6cb088f340b5 35 fields · synced May 30, 2026