Cleared Traditional

K191051 - ARGOS (FDA 510(k) Clearance)

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

K191051 · Santec Corporation · Ophthalmic device
May 2019
Decision
27d
Days
Class 2
Risk

K191051 is an FDA 510(k) clearance for the ARGOS. Classified as Device, Analysis, Anterior Segment (product code MXK), Class II - Special Controls.

Submitted by Santec Corporation (Komaki, JP). The FDA issued a Cleared decision on May 16, 2019 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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.

Submission Details

510(k) Number K191051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2019
Decision Date May 16, 2019
Days to Decision 27 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 156d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code MXK Device, Analysis, Anterior Segment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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.