510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN160030Unknown

Oculeve Intranasal Tear Neurostimulator Device

Oculeve, Inc., South San Francisco CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN160030 is the FDA 510(k) clearance record for Oculeve Intranasal Tear Neurostimulator Device, a class II device, cleared for Oculeve, Inc. on under FDA product code PQJ (Intranasal Electrostimulation Device). FDA's definition for product code PQJ reads: "This device type is intended to temporarily increase tear production using neurostimulation in adult patients". FDA records list one 510(k) clearance for Oculeve, Inc. As of , FDA records show no recalls naming DEN160030.

Clearance record

Decision date
Received
(291 days to decision)
Product code
PQJ Intranasal Electrostimulation Device
Regulation
21 CFR 886.5300
Device class
Class II
Review panel
Ophthalmic
Applicant
Oculeve, Inc. 395 Oyster Pt. Blvd., South San Francisco CA
Third party review
No

Clearances, product code PQJ

Trailing 12 months

FDA records hold no clearances under product code PQJ in the trailing twelve months.

FDA records show no clearances under product code PQJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PQJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260