Cleared Traditional

K865111 - CHARTER HARD CONTACT LENS CLEANING SOLUTION (FDA 510(k) Clearance)

K865111 · Paco Pharmaceutical Services, Inc. · Ophthalmic device
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Jan 1987
Decision
20d
Days
-
Risk

K865111 is an FDA 510(k) clearance for the CHARTER HARD CONTACT LENS CLEANING SOLUTION. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Paco Pharmaceutical Services, Inc. (Lakewood, US). The FDA issued a Cleared decision on January 20, 1987 after a review of 20 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 Paco Pharmaceutical Services, Inc. devices

Submission Details

510(k) Number K865111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1986
Decision Date January 20, 1987
Days to Decision 20 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 110d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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