Cleared Traditional

K821897 - LENS

K821897 is an FDA 510(k) clearance for LENS, manufactured by Mortan, Inc.. The device is a Class 1 Ophthalmic device with product code KYG cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K821897 · Mortan, Inc. · Ophthalmic device
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Jan 1983
Decision
191d
Days
Class 1
Risk

K821897 is an FDA 510(k) clearance for the LENS. Classified as Device, Irrigation, Ocular Surgery (product code KYG), Class I - General Controls.

Submitted by Mortan, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1983 after a review of 191 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4360 - 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 Mortan, Inc. devices

FDA 510(k) Submission Details - K821897

510(k) Number K821897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1982
Decision Date January 05, 1983
Days to Decision 191 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 110d · This submission: 191d
Pathway characteristics
Predicate-based equivalence.

KYG Device Classification - Class 1, General Controls

Product Code KYG Device, Irrigation, Ocular Surgery
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4360
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.