DeviceClearance

Product code QBR— Ophthalmic

TrueTear Intranasal Tear Neurostimulator

Classification name
Intranasal Electrostimulation Device For Dry Eye Symptoms
Device class
Class 2
Regulation
21 CFR 886.5310
Advisory panel
Ophthalmic
Total cleared
2
First cleared
Most recent

FDA classification definition

“This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only.”

— U.S. Food and Drug Administration, device classification record for product code QBR under 21 CFR 886.5310, via openFDA

Market context for product code QBR

FDA has cleared 2 devices under product code QBR between 2018 and 2020, 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.

Clearances per year

Top applicants under product code QBR

Recent clearances under product code QBR

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