FDA.reportPublic FDA data

ALADDIN TMS

Primary DI
08034028770180
Brand
ALADDIN TMS
Company
VISIA IMAGING SRL
Model
1240400
Catalog number
1240400
Published
2016-09-26
Public version status
Update
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
K131567000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131567000ALADDINVisia Imaging S.R.L.2014-06-05HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08034028770180PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08034028770180080340287701808034028770180

GMDN Terms#

Term, Definition table
TermDefinition
Corneal topography system analyserA mains electricity (AC-powered) ophthalmic device used to measure the curvature and concentricity of the anterior corneal surface. It is typically a dedicated videokeratoscope that uses Placido imaging (involves a disk with concentric white and black rings) to provide keratometric and topographic measurements and images. It will typically output to a dedicated computer workstation or external computer with installed dedicated application software.

Regulatory Flags#

DUNS number
447668039
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08034028770609TERA Dry Eye ImagerTERA Dry Eye Imager42-0002941US2025-08-06
08034028770524TOPCONSOLOS LITE42-00027702025-02-20
08034028770562TOPCONCC-100 HW6.03002002025-02-20
08034028770517ESSILORMYOPIA EXPERT 700BMT000042024-11-04
08034028770487MYAHMYAH42-0000983US2023-10-12
08034028770470SeeNASeeNASEENA0061002023-05-26
08034028770319TOPCONCC-1001205033002022-09-15
08034028770326TOPCONCC-100XP1205132002022-09-15
08034028770401TOPCONSOLOS42-00014172022-09-15
08034028770418TOPCONHENSON 9000HENSON90002022-09-15
08034028770463MYOPIA EXPERT 700MYOPIA EXPERT 700BMT000042022-06-22
08034028770456MYAHMYAH42-0000983US2022-06-14
08034028770364ALADDIN-M12402132020-09-09
08034028770203ALADDIN HW3.0TEM1240212EXTEM1240212EX2016-11-03
08034028770333ALADDIN HW3.01240212US1240212US2016-12-14

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Primary DI, Brand, Company table
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00852194002137SL-5000Hightech American Industrial Labs IncHJO2025-12-18
04547451338321INAMIINAMI & CO., LTD.HJO2025-08-29
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00840124520769PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520776PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
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00840124520806IntraLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520813IntraLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520820LapiLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520837DynaBridgeFUSION ORTHOPEDICS, LLCHJO2025-05-19
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00840124520929PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520936PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
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00852164007353Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
04987646810476KOWA SL-19KOWA COMPANY,LTD.HJO2024-10-08
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