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

Intranasal Electrostimulation Device

21 CFR 886.5300 / Ophthalmic
FDA source (opens on fda.gov)

PQJ is the FDA product code for Intranasal Electrostimulation Device, a class II device type, regulated under 21 CFR 886.5300. FDA's definition for this code reads: "This device type is intended to temporarily increase tear production using neurostimulation in adult patients". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PQJ
Device name
Intranasal Electrostimulation Device
FDA definition
This device type is intended to temporarily increase tear production using neurostimulation in adult patients.
Regulation
21 CFR 886.5300
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PQJ

By decision year
1 clearance under product code PQJ with a decision year between 2017 and 2017, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PQJ by decision year
YearClearances
20171

Applicants with the most clearances

Product code PQJ
Applicants holding the most 510(k) clearances under product code PQJ
ApplicantClearances
Oculeve, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code