VISUMAX

Primary DI
04049471095111
Brand
VISUMAX
Company
Carl Zeiss Meditec AG
Model
VISUMAX 800 or 09511
Device description
The VISUMAX 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 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 lower or equal 0.50 D in magnitude.
Published
2024-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OTLFemtosecond Laser System For Refractive Correction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTLFemtosecond Laser System For Refractive CorrectionUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P150040012

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P150040012VISUMAX FEMTOSECOND LASERCarl Zeiss Meditec, Inc.2016-09-13OTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049471095111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049471095111040494710951114049471095111

GMDN Terms#

Term, Definition table
TermDefinition
Femtosecond ophthalmic solid-state laser systemA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Weight520Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure20.671 Inches of Mercury31.302 Inches of Mercury
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature64.4 Degrees Fahrenheit77 Degrees Fahrenheit
Storage Environment Atmospheric Pressure14.765 Inches of Mercury31.302 Inches of Mercury
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
314594680
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049471097153SL 220SL 8002026-01-13
04049471091489VISULASVISULAS yag2026-01-12
04049471091496VISULASVISULAS combi2026-01-12
04049471091502VISULAS greenVISULAS green2026-01-12
04049471090260AT 030AT 0302018-12-04
04049471091229VISULAS TrionVISULAS Trion, VISULAS Trion VITE2016-09-20
04049471091403VISULAS 532sVISULAS 532s, VISULAS 532s VITE2016-09-20
04049539072122QEVO72122017-08-24
04049539072139QEVO ECU72132017-08-24
04049539105509INTRABEAM Spherical Sizer Set309121-9100-0002025-06-20
04049539105516INTRABEAM SMART Spherical Applicator309120-9015-002025-05-14
04049539105523INTRABEAM SMART Spherical Applicator 309120-9020-0002025-05-14
04049539105530INTRABEAM SMART Spherical Applicator 309120-9025-0002025-05-14
04049539105547INTRABEAM SMART Spherical Applicator (35 mm)309120-9035-0002025-05-14
04049539105554INTRABEAM SMART Spherical Applicator (35mm)309120-9035-0002025-05-14
04049539105561INTRABEAM SMART Spherical Applicator (40mm)309120-9040-0002025-05-14
04049539105578INTRABEAM SMART Spherical Applicator (45mm)309120-9045-0002025-05-14
04049539101563INTRABEAM® Spherical Applicator 1.5 cm304534-6000-5572017-04-14
04049539101570INTRABEAM® Spherical Applicator 2.0 cm304534-6000-5582017-04-14
04049539101587INTRABEAM® Spherical Applicator 2.5 cm304534-6000-5592017-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04049471110142Treatment Pack (Size M)Carl Zeiss Meditec AGOTL2024-02-09
04049471110159Treatment Pack (Size L)Carl Zeiss Meditec AGOTL2024-02-09
04049471110166Treatment Pack (Type KP)Carl Zeiss Meditec AGOTL2024-02-09
04049471110135Treatment Pack (Size S)Carl Zeiss Meditec AGOTL2024-02-08
04049471095036VisuMaxCarl Zeiss Meditec AGOTL2016-09-23
04049471110043Treatment Pack (Size S)Carl Zeiss Meditec AGOTL2016-09-23