Cleared Traditional

KLAAS IOL LENSFOLDER (K930628) - FDA 510(k) Clearance

Class I Ophthalmic device.

K930628 · Bova Intl. · Ophthalmic device
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Feb 1995
Decision
729d
Days
Class 1
Risk

K930628 is an FDA 510(k) clearance for the KLAAS IOL LENSFOLDER. Classified as Lens, Guide, Intraocular (product code KYB), Class I - General Controls.

Submitted by Bova Intl. (Fort Worth, US). The FDA issued a Cleared decision on February 7, 1995 after a review of 729 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4300 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Bova Intl. devices

Submission Details

510(k) Number K930628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1993
Decision Date February 07, 1995
Days to Decision 729 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
619d slower than avg
Panel avg: 110d · This submission: 729d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYB Lens, Guide, Intraocular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.4300
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.