Cleared Traditional

AQUALUX LENS CASE (K862811) - FDA 510(k) Clearance

K862811 · Safeway Products, Inc. · Ophthalmic device
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Sep 1986
Decision
41d
Days
-
Risk

K862811 is an FDA 510(k) clearance for the AQUALUX LENS CASE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Safeway Products, Inc. (Middletown, US). The FDA issued a Cleared decision on September 3, 1986 after a review of 41 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Safeway Products, Inc. devices

Submission Details

510(k) Number K862811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1986
Decision Date September 03, 1986
Days to Decision 41 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 110d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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