Cleared Traditional

K180895 - Alleye (FDA 510(k) Clearance)

Class I Ophthalmic device.

K180895 · Oculocare Medical AG · Ophthalmic device
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Jun 2018
Decision
83d
Days
Class 1
Risk

K180895 is an FDA 510(k) clearance for the Alleye. Classified as Grid, Amsler (product code HOQ), Class I - General Controls.

Submitted by Oculocare Medical AG (Zurich, CH). The FDA issued a Cleared decision on June 27, 2018 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1330 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oculocare Medical AG devices

Submission Details

510(k) Number K180895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2018
Decision Date June 27, 2018
Days to Decision 83 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 110d · This submission: 83d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HOQ Grid, Amsler
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1330
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.