FDA.reportPublic FDA data

NOVA EYE INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30056415453005641545NOVA EYE INC.1Y2026-01-0141316 Christy St Fremont CA US 94538

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00893872001059iTrack 250A - Canaloplasty Microcatheter KitKit Contents:(1) Canaloplasty Microcatheter iTrack 250A(1) Opthalmic Viscoinjector1-888-846-4724canaloplasty@ellex.com
00893872001059iTrack 250A - Canaloplasty Microcatheter KitKit Contents:(1) Canaloplasty Microcatheter iTrack 250A(1) Opthalmic Viscoinjector1-510-291-1300iTrack@nova-eye.com
00893872001059iTrack 250A - Canaloplasty Microcatheter KitKit Contents:(1) Canaloplasty Microcatheter iTrack 250A(1) Opthalmic Viscoinjector1-510-291-1300info@nova-eye.com
00893872001073iLumin - Optical Light Source- Fiberoptic Illuminator1-888-846-4724canaloplasty@ellex.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2721532059891918K221872ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemMPA2023-03-30
2721531896374776K080067ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETERMPA2008-07-18
2721531646805374K062259ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100MPA2006-08-15
2721531045848413K050716ISCIENCE SURGICAL VISCOINJECTORMRH2005-04-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MPA32023-03-30
MRH12005-04-21

PMN#

GUDID#