OPTOVUE, INC.

Address:2800 Bayview Dr,FREMONT,CA,94538,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Ophthalmoscope, Ac-Powered (HLI) (10) Tomography, Optical Coherence (OBO) (3)

Premarket Exempt

No Yes

Clear

Avanti - 00858848006001 Catalog Number : 700-48076-004

Device Description : RTVue XR System w/ CAM w/ 120V Table w/ 45pt Fixation

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : OBO, HLI

Prescription Use : Yes

Device Count : 1

iScan - 00858848006018 Catalog Number : 700-49428-003

Device Description : iVue 500 System

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

Avanti - 00858848006025 Catalog Number : 700-48098-004

Device Description : RTVue XR System w/ CAM w/ 230V Table w/ 45pt Fixation

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : OBO, HLI

Prescription Use : Yes

Device Count : 1

Avanti - 00858848006032 Catalog Number : 500-47760-005

Device Description : Assy Scanner Integration w/CAM XR w/ 45pt Fixation

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : OBO, HLI

Prescription Use : Yes

Device Count : 1

iVue - 00858848006049 Catalog Number : 700-47817-004

Device Description : iVue NR Complete System w/ 120V Table

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iVue - 00858848006056 Catalog Number : 700-47818-004

Device Description : iVue NR Complete System USCFG w/ 120V Table

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iVue - 00858848006063 Catalog Number : 700-47826-005

Device Description : iVue NR System w/ Laptop 120V

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iVue - 00858848006070 Catalog Number : 700-47827-005

Device Description : iVue NR System USCFG w/ Laptop 120V

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iVue - 00858848006087 Catalog Number : 700-48355-005

Device Description : iVue NR System iWellness w/ Laptop USCFG 120V

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

iVue - 00858848006094 Catalog Number : 700-48577-004

Device Description : iVue NR Complete System USCFG w/ 230V Table

Device Class : 2

Duns Number: 196500461

Premarket Exempt : No

Product Code : HLI

Prescription Use : Yes

Device Count : 1

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