meddevicedb.com FDA Device Reference

iTEAR Neurostimulator

DEN190026 Class II Direct
Decision Date
2020-05-01
Sponsor / Applicant
Olympic Ophthalmics, Inc.

Technical Specification

510(k) Submission ID DEN190026
Product Code QKV
Medical Specialty / Panel Ophthalmic
Regulation Citation 21 CFR 886.5305
Decision Date 2020-05-01
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

iTEAR Neurostimulator received FDA 510(k) clearance under submission number DEN190026, sponsored by Olympic Ophthalmics, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2020-05-01.

Classification & Regulation

This clearance is catalogued under FDA product code QKV and 21 CFR 886.5305, within the Ophthalmic review panel as a Class II device.