Cleared Traditional

K150754 - ARGOS

K150754 is the FDA 510(k) clearance for ARGOS by Santec Corporation. It is a Class 2 Ophthalmic device (product code MXK) cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K150754 · Santec Corporation · Ophthalmic device
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Oct 2015
Decision
193d
Days
Class 2
Risk

K150754 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 October 2, 2015 after a review of 193 days - an extended review 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: 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.

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Submission Details

510(k) Number K150754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2015
Decision Date October 02, 2015
Days to Decision 193 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
83d slower than avg
Panel avg: 110d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.