Cleared Traditional

EASY EYES TM LENS CARRYING CASE (K853870) - FDA 510(k) Clearance

K853870 · Applied Laboratories, Inc. · Ophthalmic device
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Dec 1985
Decision
84d
Days
-
Risk

K853870 is an FDA 510(k) clearance for the EASY EYES TM LENS CARRYING CASE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Applied Laboratories, Inc. (Columbus, US). The FDA issued a Cleared decision on December 10, 1985 after a review of 84 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 Applied Laboratories, Inc. devices

Submission Details

510(k) Number K853870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1985
Decision Date December 10, 1985
Days to Decision 84 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 110d · This submission: 84d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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