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

Intranasal Electrostimulation Device For Dry Eye Symptoms

21 CFR 886.5310 / Ophthalmic
FDA source (opens on fda.gov)

QBR is the FDA product code for Intranasal Electrostimulation Device For Dry Eye Symptoms, a class II device type, regulated under 21 CFR 886.5310. FDA's definition for this code reads: "This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QBR
Device name
Intranasal Electrostimulation Device For Dry Eye Symptoms
FDA definition
This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only.
Regulation
21 CFR 886.5310
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
2
Ingested recalls
0

Clearances, product code QBR

By decision year
2 clearances under product code QBR with a decision year between 2018 and 2020, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QBR by decision year
YearClearances
20181
20201

Applicants with the most clearances

Product code QBR
Applicants holding the most 510(k) clearances under product code QBR
ApplicantClearances
Allergan2

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code QBR.