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FDA PRODUCT CODE · CLASS II

QBR — Intranasal Electrostimulation Device For Dry Eye Symptoms

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

DEVICE CLASS
Class II
REGULATION
21 CFR 886.5310
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
0
510(K)/PMA CLEARANCES
0
RECALL ENTRIES

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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