Cleared Traditional

K823528 - GLISLENS

K823528 · Bio-Products, Inc. · Ophthalmic device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Dec 1982

Decision

22d

Days

Risk

K823528 is an FDA 510(k) clearance for the GLISLENS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Bio-Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1982 after a review of 22 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 Bio-Products, Inc. devices

Submission Details

510(k) Number	K823528 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 30, 1982
Decision Date	December 22, 1982
Days to Decision	22 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

88d faster than avg

Panel avg: 110d · This submission: 22d

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 K823528.

SIGHT SAVER ALL PURPOSE LENS CARRYING CASE

K852384 · Bausch & Lomb, Inc. · Jul 1985

SENSITIVE EYES

K832706 · Bausch & Lomb, Inc. · Oct 1983

CLERZ LUBRICATING & REWETTING EYE DROPS

K830740 · CooperVision, Inc. · Jun 1983

PRE-SERT

K822706 · Allergan, Inc. · Oct 1982

CLEAN-N-SOAK

K822707 · Allergan, Inc. · Oct 1982

LIQUIFILM WETTING SOLUTION

K821051 · Allergan, Inc. · May 1982

Related FDA 510(k) Regulatory Insights

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

Manufacturer of K823528

Bio-Products, Inc.

Mchenry, IL · US

Regulatory profile

1 submissions 1 cleared

100% clearance rate · Active in Ophthalmic

Data Intelligence Layer

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 . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active