Cleared Traditional

UVASORB-400 (K854442) - FDA 510(k) Clearance

K854442 · Optatint, Inc. · Ophthalmic device
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Feb 1986
Decision
106d
Days
-
Risk

K854442 is an FDA 510(k) clearance for the UVASORB-400. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Optatint, Inc. (Englewood, US). The FDA issued a Cleared decision on February 19, 1986 after a review of 106 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 Optatint, Inc. devices

Submission Details

510(k) Number K854442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1985
Decision Date February 19, 1986
Days to Decision 106 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 110d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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