Cleared Traditional

K862952 - CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES (FDA 510(k) Clearance)

K862952 · Paco Pharmaceutical Services, Inc. · Ophthalmic device
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Sep 1986
Decision
51d
Days
-
Risk

K862952 is an FDA 510(k) clearance for the CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Paco Pharmaceutical Services, Inc. (Lakewood, US). The FDA issued a Cleared decision on September 25, 1986 after a review of 51 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 K862952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1986
Decision Date September 25, 1986
Days to Decision 51 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 110d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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