Cleared Traditional

K213623 - iTEAR100 Neurostimulator (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213623 · Olympic Ophthalmics · Ophthalmic device
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Mar 2022
Decision
120d
Days
Class 2
Risk

K213623 is an FDA 510(k) clearance for the iTEAR100 Neurostimulator. Classified as Electromechanical Tear Stimulator (product code QKV), Class II - Special Controls.

Submitted by Olympic Ophthalmics (Issaquah, US). The FDA issued a Cleared decision on March 16, 2022 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5305 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympic Ophthalmics devices

Submission Details

510(k) Number K213623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2021
Decision Date March 16, 2022
Days to Decision 120 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 110d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QKV Electromechanical Tear Stimulator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5305
Definition This Device Type Is A Non-implantable Device Intended To Increase Tear Production Via Mechanical Stimulation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice Hogan

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.