510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Nova Eye Inc.

Fremont, CA, US

NOVA EYE INC. appears in FDA device records in Fremont, CA. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
2
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Nova Eye Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Ellex iScience, Inc.enforcement report, recall

510(k) clearance history

FDA records hold 1 510(k) clearance for Nova Eye Inc. in 2026.

Clearances by year, as a table
510(k) clearance decisions for Nova Eye Inc., by decision year
YearClearances
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)MPASubstantially Equivalent

Registered establishments

FDA registered establishments for Nova Eye Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30056415453005641545NOVA EYE INC.41316 Christy St, Fremont, CA 94538 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0011-2019ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.Sterility failure found in one of the units in the lot.Class IITerminated
Z-2590-2014iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile. Indicated for fluid infusion and aspiration during surgery.One lot may not have been properly sealed, resulting in a non-sterile device.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain