FDA.reportPublic FDA data

IS-5500

Primary DI
00850053428616
Brand
IS-5500
Company
TOPCON HEALTHCARE INC
Model
23060-11-000-GV
Device description
IS-5500 OPHTHALMIC STAND GRAND VISION 110V; AC-Powered Ophthalmic Instrument Stand
Published
2024-05-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HMFStand, Instrument, Ac-Powered, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMFStand, Instrument, Ac-Powered, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850053428616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850053428616008500534286168500534286160850053428616

GMDN Terms#

Term, Definition table
TermDefinition
Static ophthalmic equipment stand, manually-adjustedA device designed as a column or post, usually with a small flat surface top, used to provide support and position control for ophthalmic devices commonly used during an ophthalmic examination/treatment (e.g., a slit lamp, keratometer, refractometer). It may have a manually-operated height adjustment function (e.g., a hydraulic foot pump or adjustable threaded column) enabling the user to align (raise/lower) the ophthalmic instruments to the eye level of the patient. It is typically stationary and may have drawers, shelves, and built-in outlets to supply low-voltage electricity to the instruments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
053547238
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003069753OC-230024045-HG-L1-0002026-05-06
00850003069760OC-230024045-HG-H1-0002026-05-06
00850003069739OC-240024048-WT-L1-0002026-03-13
00850003069630OC-220024046-PL-H2-0002025-10-31
00850003069647OC-220024046-PL-L2-0002025-10-31
00850003069654OC-220024046-TL-H1-0002025-10-31
00850003069661OC-220024046-TL-L1-0002025-10-31
00850003069678OC-220024046-TL-H2-0002025-10-31
00850003069685OC-220024046-TL-L2-0002025-10-31
00850003069692OC-220024046-WT-H1-0002025-10-31
00850003069708OC-220024046-WT-L1-0002025-10-31
00850003069715OC-220024046-WT-H2-0002025-10-31
00850003069722OC-220024046-WT-L2-0002025-10-31
00850053428746OC-220024046-AU-H1-0002025-10-31
00850053428753OC-220024046-AU-L1-0002025-10-31
00850053428760OC-220024046-AU-H2-0002025-10-31
00850053428777OC-220024046-AU-L2-0002025-10-31
00850053428784OC-220024046-CR-H1-0002025-10-31
00850053428791OC-220024046-CR-L1-0002025-10-31
00850053428807OC-220024046-CR-H2-0002025-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436566190015TOPCONANTONI CARLES SAHMF2026-06-01
00850020301638RelianceHAAG-STREIT USA, INC.HMF2026-05-29
05907642694435Refraction UnitMDT SP Z O OHMF2025-08-08
00850020301607RelianceHAAG-STREIT USA, INC.HMF2025-08-04
00850020301614RelianceHAAG-STREIT USA, INC.HMF2025-08-04
00850020301621RelianceHAAG-STREIT USA, INC.HMF2025-08-04
05907642694459Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694466Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694473Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694480Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694497Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694510Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694534Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694541Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694565Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694589Refraction UnitMDT SP Z O OHMF2025-07-16
05907642694596Refraction UnitMDT SP Z O OHMF2025-07-16
00850020301584RelianceHAAG-STREIT USA, INC.HMF2025-05-21
00850020301539RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301546RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301553RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301560RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00850020301577RelianceHAAG-STREIT USA, INC.HMF2025-04-24
00628308210015LombartINNOVA Medical Ophthalmics IncHMF2025-02-20
00628308210022S4 OptikINNOVA Medical Ophthalmics IncHMF2025-02-20
00628308210039MarcoINNOVA Medical Ophthalmics IncHMF2025-02-20
G699Q90630EyeCheq KioskEYECHEQ INC.HMF2024-10-17
05907642694442Refraction UnitMDT SP Z O OHMF2024-06-14
00850053428517IS-6500TOPCON HEALTHCARE INCHMF2024-05-17
00850053428524IS-6500TOPCON HEALTHCARE INCHMF2024-05-17