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.

FDA 510(k) Submission Details - K813528

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
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

84d faster than avg

Panel avg: 110d · This submission: 26d

Pathway characteristics

Predicate-based equivalence.

HPX Device Classification - Class 0,

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

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 42

Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K813528.

STERICIDAL

K820325 · Breger Mueller West · Apr 1982

BAUSCH & LOMB STERILE ALL PURPOSE SOLU

K820511 · Bausch & Lomb, Inc. · Apr 1982

CONCENTRATED CLEANER FOR HARD CONTACTS

K820818 · Bausch & Lomb, Inc. · Apr 1982

CONTACT LENS MATERL

K811010 · Paragon Optical Co. · Dec 1981

LENSINE EXTRA STRENGTH CLEANER

K812433 · CooperVision, Inc. · Sep 1981

BARNES-HIND WEEKLY CLEANER

K812135 · Barnes-Hind, Inc. · Aug 1981

FDA 510(k) Resources - Ophthalmic

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K813528

The Plactory

Mchenry, IL · US

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Ophthalmic

View all devices by The Plactory →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: January 12, 1982. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: November 2026.

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