FDA.reportPublic FDA data

S4 Optik

Primary DI
00628308210251
Brand
S4 Optik
Company
INNOVA Medical Ophthalmics Inc
Model
1000-CB-H
Device description
S4OPTIK Combination Chair & Stand - Model 1000-CB-H
Published
2025-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HMEChair, Ophthalmic, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMEChair, Ophthalmic, Ac-PoweredOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628308210251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628308210251006283082102516283082102510628308210251

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic chair, line-poweredA mains electricity (AC-powered) device designed to position a patient in a seated or reclined posture for easy access and patient comfort during an ophthalmic examination, treatment, or surgical intervention. It will typically have powered raise/lower functions and may be freestanding or connected to another device or system. It is not designed to position the patient completely horizontally during surgery (i.e., it is not an operating table).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
243325332
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628308210435S4OptikTA1-550-NA2026-03-31
00628308210459S4OptikTA1-552-NA2026-03-31
00628308210473S4OptikRT-600-SN-GRY2026-03-31
00628308210480LombartRT-600-LN-GRY2026-03-31
00628308210497S4OptikRT-600-SN-BLK2026-03-31
00628308210503LombartRT-600-LN-BLK2026-03-31
00628308210510S4OptikRT-600-SP-BLK2026-03-31
00628308210527LombartRT-600-LP-BLK2026-03-31
00628308210534LombartPD-12026-03-31
00628308210541S4OptikPD-12026-03-31
00628308210558PD-1PD-12026-03-31
00628308210336S4 OPTIKTA1INTT-36172025-08-21
00628308210343S4 OPTIKTA1INTT-2E2025-08-21
00628308210350S4 OPTIKTA1INTT-12025-08-21
00628308210367S4 OPTIK400-1002025-08-21
00628308210374S4 OPTIK222-0012025-08-21
00628308210381S4 OPTIK280-0002025-08-21
00628308210398S4 OPTIK281-0002025-08-21
00628308210305S4 OptikTA1S4-2UP2025-06-04
00628308210312S4 OptikTA1S4-2UP-Lx2025-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436566190022TOPCONANTONI CARLES SAHME2026-06-01
08436566190039TOPCONANTONI CARLES SAHME2026-06-01
08436566190046TOPCONANTONI CARLES SAHME2026-06-01
08436566190053TOPCONANTONI CARLES SAHME2026-06-01
00850003069753OC-2300TOPCON HEALTHCARE INCHME2026-05-06
00850003069760OC-2300TOPCON HEALTHCARE INCHME2026-05-06
00850003069739OC-2400TOPCON HEALTHCARE INCHME2026-03-13
04057027018781UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027071816UFSK-OSYS Treatment chairUFSK-International OSYS GmbHHME2026-03-02
04057027212998UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027256831UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027338476UFSK-OSYS Treatment chairUFSK-International OSYS GmbHHME2026-03-02
04057027552995UFSK-OSYS Treatment chairUFSK-International OSYS GmbHHME2026-03-02
04057027609606UFSK-OSYS Treatment chairUFSK-International OSYS GmbHHME2026-03-02
04057027615751UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027619605UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027637050UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027659212UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
04057027948156UFSK-OSYS Surgeon's chairUFSK-International OSYS GmbHHME2026-03-02
00850003069630OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069647OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069654OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069661OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069678OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069685OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069692OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069708OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069715OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850003069722OC-2200TOPCON HEALTHCARE INCHME2025-10-31
00850053428746OC-2200TOPCON HEALTHCARE INCHME2025-10-31