Cleared Traditional

K813528 - LENS-PAC

K813528 · The Plactory · Ophthalmic device
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Jan 1982
Decision
26d
Days
-
Risk

K813528 is an FDA 510(k) clearance for the LENS-PAC. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by The Plactory (Mchenry, US). The FDA issued a Cleared decision on January 12, 1982 after a review of 26 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 The Plactory devices

Submission Details

510(k) Number K813528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1981
Decision Date January 12, 1982
Days to Decision 26 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 110d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 19
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K813528.
BLINK-N-CLEAN
K821055 · Allergan, Inc. · May 1982
BAUSCH & LOMB STERILE ALL PURPOSE SOLU
K820511 · Bausch & Lomb, Inc. · Apr 1982
CONCENTRATED CLEANER FOR HARD CONTACTS
K820818 · Bausch & Lomb, Inc. · Apr 1982
LENSINE EXTRA STRENGTH CLEANER
K812433 · CooperVision, Inc. · Sep 1981
CONTACT LENS CLEANER
K812172 · Alcon Laboratories · Aug 1981
DURALITE LENS
K800192 · American Optical Corp. · Mar 1980