Cleared Traditional

HARD CONTACT LENS CLEANER (K832810) - FDA 510(k) Clearance

K832810 · Blairex Laboratories, Inc. · Ophthalmic device
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Sep 1983
Decision
42d
Days
-
Risk

K832810 is an FDA 510(k) clearance for the HARD CONTACT LENS CLEANER. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Blairex Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 42 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 Blairex Laboratories, Inc. devices

Submission Details

510(k) Number K832810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1983
Decision Date September 29, 1983
Days to Decision 42 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 110d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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