DeviceClearance

Product code PQJ— Ophthalmic

Oculeve Intranasal Tear Neurostimulator Device

Classification name
Intranasal Electrostimulation Device
Device class
Class 2
Regulation
21 CFR 886.5300
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification definition

“This device type is intended to temporarily increase tear production using neurostimulation in adult patients.”

— U.S. Food and Drug Administration, device classification record for product code PQJ under 21 CFR 886.5300, via openFDA

Market context for product code PQJ

FDA has cleared 1 device under product code PQJ, all in 2017, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PQJ

Recent clearances under product code PQJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.