Cleared Traditional

K854442 - UVASORB-400

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

FDA 510(k) Submission Details - K854442

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.

HPX Device Classification - Class 0,

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

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 20
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K854442.
STYLEKEEPER CONTACT LENS CARRYING CASE
K861643 · Allergan, Inc. · Jun 1986
LENSKEEPER CONTACT LENS CARRYING CASE
K861642 · Allergan, Inc. · May 1986
BAUSCH & LOMB LENS CARRYING CASE
K854968 · Bausch & Lomb, Inc. · Apr 1986
SIGHT SAVER ALL PURPOSE LENS CARRYING CASE
K852384 · Bausch & Lomb, Inc. · Jul 1985
SENSITIVE EYES
K832706 · Bausch & Lomb, Inc. · Oct 1983
CLERZ LUBRICATING & REWETTING EYE DROPS
K830740 · CooperVision, Inc. · Jun 1983