Nova Eye, Inc.

Address:41316 Christy St,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

Endoilluminator (MPA) (2) Pump, Infusion, Ophthalmic (MRH) (2) Cannula, Ophthalmic (HMX) (1) System, Imaging, Pulsed Echo, Ultrasonic (IYO) (1) Transducer, Ultrasonic, Diagnostic (ITX) (1)

Premarket Exempt

Clear

iCAP Imaging Cap - 00893872001028 Catalog Number : 200549

Device Description : Imaging Cap

Device Class : 2

Duns Number: 079755637

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

iTrack 250A - 00893872001059 Catalog Number : 200478

Device Description : Canaloplasty Microcatheter KitKit Contents:(1) Canaloplasty Microcatheter iTrack Canaloplasty Microcatheter KitKit Contents:(1) Canaloplasty Microcatheter iTrack 250A(1) Opthalmic Viscoinjector

Device Class : 1

Duns Number: 079755637

Premarket Exempt : No

Product Code : HMX, MRH, MPA

Prescription Use : Yes

Device Count : 1

iLumin - 00893872001073 Catalog Number : 200529

Device Description : Optical Light Source- Fiberoptic Illuminator

Device Class : 2

Duns Number: 079755637

Premarket Exempt : No

Product Code : MPA

Prescription Use : Yes

Device Count : 1

ViscoInjector - 00893872001585 Catalog Number : 202038

Device Description : Opthalmic Viscoelastic Injector

Device Class : 2

Duns Number: 079755637

Premarket Exempt : No

Product Code : MRH

Prescription Use : Yes

Device Count : 1

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