Cleared Traditional

KERATOPLASTY SUTURING LENS (K940106) - FDA 510(k) Clearance

K940106 · Visionary Technologies of Miami, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
May 1994
Decision
135d
Days
-
Risk

K940106 is an FDA 510(k) clearance for the KERATOPLASTY SUTURING LENS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Visionary Technologies of Miami, Inc. (Miami, US). The FDA issued a Cleared decision on May 25, 1994 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel. 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 Visionary Technologies of Miami, Inc. devices

Submission Details

510(k) Number K940106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1994
Decision Date May 25, 1994
Days to Decision 135 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
25d slower than avg
Panel avg: 110d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPX Lens, Contact (polymethylmethacrylate)
Device Class -