Cleared Traditional

ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY (K874591) - FDA 510(k) Clearance

K874591 · Vitreo Dynamics, Co. · Ophthalmic device
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May 1988
Decision
176d
Days
-
Risk

K874591 is an FDA 510(k) clearance for the ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Vitreo Dynamics, Co. (Southaven, US). The FDA issued a Cleared decision on May 3, 1988 after a review of 176 days - an extended review cycle.

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 Vitreo Dynamics, Co. devices

Submission Details

510(k) Number K874591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1987
Decision Date May 03, 1988
Days to Decision 176 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 110d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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