Cleared Traditional

LENSINE EXTRA STRENGTH CLEANER (K812433) - FDA 510(k) Clearance

K812433 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1981
Decision
27d
Days
-
Risk

K812433 is an FDA 510(k) clearance for the LENSINE EXTRA STRENGTH CLEANER. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on September 21, 1981 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 CooperVision, Inc. devices

Submission Details

510(k) Number K812433 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1981
Decision Date September 21, 1981
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 -