FDA.reportPublic FDA data

VISULAS 532s

Primary DI
04049471091403
Brand
VISULAS 532s
Company
Carl Zeiss Meditec AG
Model
VISULAS 532s, VISULAS 532s VITE
Device description
The VISULAS 532s Laser System with the VITE option is intended for use in retinal, panretinal, focal and grid photocoagulation of ocular tissues in the treatment of diseases of the eye including:* Proliferative and nonproliferative diabetic retinopathy* Macular edema* Branch and central retinal vein occlusion* Lattice degeneration* Retinal tears and detachments
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K013402000
K100035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K013402000VISULAS 532SCarl Zeiss, Inc.2001-11-14GEX
K100035000MODEL VISULAS 532S LASER WITH THE VITE OPTIONCarl Zeiss Meditec, AG2010-03-17GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049471091403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049471091403040494710914034049471091403

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic solid-state laser system, photocoagulation/photostimulationA mains electricity (AC-powered) device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam, in which the frequency is doubled, intended for: 1) ocular photocoagulation procedures (e.g., coagulate abnormal vascular tissue in the retina); and/or 2) dosimetery-controlled photostimulation of retinal pigment epithelium (RPE) cells to reverse macular degeneration. It typically includes a light source and controls/foot-switch, and has a built-in slit lamp biomicroscope, or is coupled to a slit lamp or indirect ophthalmoscope by fixed mirrors; it may include a dosimetry sensor. It does not include femtosecond pulsing or fundus imaging technology.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

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
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
04049539101594INTRABEAM® Spherical Applicator 3.0 cm304534-6000-5602017-04-14

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