FDA.reportPublic FDA data

S4 Optik

Primary DI
00628308210268
Brand
S4 Optik
Company
INNOVA Medical Ophthalmics Inc
Model
1000-CB-H-L
Device description
S4OPTIK Combination Chair & Stand - Model 1000-CB-H-L
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
00628308210268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628308210268006283082102686283082102680628308210268

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
00628308210565S4OptikTA1S4-346-0002026-11-03
00628308210589S4OptikST1S4-344-0002026-11-03
00628308210596S4OptikST1S4-348-0002026-11-03
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850003069791OC-2300TOPCON HEALTHCARE INCHME2026-10-19
00850003069784OC-2300TOPCON HEALTHCARE INCHME2026-08-18
00850003069777OC-2300TOPCON HEALTHCARE INCHME2026-08-03
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