FDA.reportPublic FDA data

VISUREF 600

Primary DI
04250668607202
Brand
VISUREF 600
Company
Carl Zeiss Vision GmbH
Model
000000-2572-424
Device description
VISUREF 600
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253834000VISUREF 600Carl Zeiss Vision GmbH2026-03-18HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250668607202PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250668607202042506686072024250668607202

GMDN Terms#

Term, Definition table
TermDefinition
Automated ophthalmic refractometerAn electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.

Regulatory Flags#

DUNS number
333928146
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250668607233ZEISS Mobile Centration000000-2750-321000000-2750-3212026-01-15
04250668606748VISU360000000-1011-377000000-1011-3772021-01-01
04250668606045VISUSCREEN 100 Compact000000-2522-536000000-2522-5362023-05-30
04250668606052VISUCORE 500 Refractor000000-2522-537000000-2522-5372023-05-30
04250668606618VISUCONSULT 500000000-2265-586000000-2265-5862021-01-01
04250668607172i.Terminal go000000-2408-309000000-2408-3092022-12-08
04250668606649i.Terminal mobile000000-2120-340000000-2120-3402021-01-01
04250668606687VISUFIT 1000000000-2351-293000000-2351-2932021-01-01
04250668606700i.Terminal 2 Station000000-2433-519000000-2433-5192021-01-01
04250668606625i.Profiler plus000000-1005-825000000-1005-8252021-01-01
04250668606663VISUFIT 1000 Platform000000-2194-446000000-2194-4462021-01-01
04250668606694i.Terminal 2000000-1898-991000000-1898-9912021-01-01
04250668606755i.Profiler plus000000-2358-727000000-2358-7272021-01-01
04250668606670Avatar Generation000000-2351-295000000-2351-2952021-01-01
04250668606724VISUSCREEN 500000000-2087-230000000-2087-2302021-01-01
04250668606717i.Terminal 2000000-2408-310000000-2408-3102021-01-22
04250668606731VISUSCREEN 100000000-2069-910000000-2069-9102021-01-01
04250668606632ATLAS Review for i. Profiler plus000000-2360-422000000-2360-4222021-01-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0695109080097866VT66 VISION TECH CO., LTD.HJO2026-04-27
04049471097153SL 220Carl Zeiss Meditec AGHJO2026-01-13
00852194002137SL-5000Hightech American Industrial Labs IncHJO2025-12-18
04547451338321INAMIINAMI & CO., LTD.HJO2025-08-29
00819034023240TalarLiftFUSION ORTHOPEDICS, LLCHJO2025-05-19
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00840124520745PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520752PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520769PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520776PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520783PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520790PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520806IntraLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520813IntraLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520820LapiLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
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00840124520929PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520936PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00852164007346Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
00852164007353Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
04987646810476KOWA SL-19KOWA COMPANY,LTD.HJO2024-10-08
04560323640940MARCOTAKAGI SEIKO CO.,LTD.HJO2024-03-14
00851158007621Eli EzerU.S. OPHTHALMIC, L.L.C.HJO2024-01-25