Cleared Traditional

K140368 - FAMILY OF DISPOSABLE LENSES (FDA 510(k) Clearance)

Class I Ophthalmic device.

K140368 · Sensor Medical Technology, LLC · Ophthalmic device
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Apr 2014
Decision
74d
Days
Class 1
Risk

K140368 is an FDA 510(k) clearance for the FAMILY OF DISPOSABLE LENSES. Classified as Prism, Gonioscopic (product code HKS), Class I - General Controls.

Submitted by Sensor Medical Technology, LLC (North Reading, US). The FDA issued a Cleared decision on April 29, 2014 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1660 - 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 Sensor Medical Technology, LLC devices

Submission Details

510(k) Number K140368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2014
Decision Date April 29, 2014
Days to Decision 74 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
36d faster than avg
Panel avg: 110d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKS Prism, Gonioscopic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1660
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.