510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193589Substantially Equivalent

TrueTear Intranasal Tear Neurostimulator

Allergan, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193589 is the FDA 510(k) clearance record for TrueTear Intranasal Tear Neurostimulator, a class II device, cleared for Allergan on under FDA product code QBR (Intranasal Electrostimulation Device For Dry Eye Symptoms). FDA's definition for product code QBR reads: "This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only". FDA records list 39 510(k) clearances for Allergan, from to . As of , FDA records show no recalls naming K193589.

Clearance record

Decision date
Received
(252 days to decision)
Product code
QBR Intranasal Electrostimulation Device For Dry Eye Symptoms
Regulation
21 CFR 886.5310
Device class
Class II
Review panel
Ophthalmic
Applicant
Allergan 2525 Dupont Dr., Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QBR

Trailing 12 months

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

FDA records show no clearances under product code QBR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QBR, 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