Cleared Traditional

K863974 - CHARTER LABORATORIES INC. LENS LUBRICANT (FDA 510(k) Clearance)

K863974 · Paco Pharmaceutical Services, Inc. · Ophthalmic device
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Nov 1986
Decision
27d
Days
-
Risk

K863974 is an FDA 510(k) clearance for the CHARTER LABORATORIES INC. LENS LUBRICANT. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Paco Pharmaceutical Services, Inc. (Lakewood, US). The FDA issued a Cleared decision on November 10, 1986 after a review of 27 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 K863974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1986
Decision Date November 10, 1986
Days to Decision 27 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 110d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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