Cleared Traditional

K810130 - OPTOCRYL CONTACT LENS BLANKS

K810130 · Optacryl, Inc. · Ophthalmic device

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Jun 1981

Decision

143d

Days

Risk

K810130 is an FDA 510(k) clearance for the OPTOCRYL CONTACT LENS BLANKS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Optacryl, Inc. (Walker, US). The FDA issued a Cleared decision on June 11, 1981 after a review of 143 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K810130

510(k) Number	K810130 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 19, 1981
Decision Date	June 11, 1981
Days to Decision	143 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

33d slower than avg

Panel avg: 110d · This submission: 143d

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 K810130.

LENSINE EXTRA STRENGTH CLEANER

K812433 · CooperVision, Inc. · Sep 1981

BARNES-HIND WEEKLY CLEANER

K812135 · Barnes-Hind, Inc. · Aug 1981

CONTACT LENS CLEANER

K812172 · Alcon Laboratories · Aug 1981

DURALITE LENS

K800192 · American Optical Corp. · Mar 1980

VISALENS ALL PURPOSE SOLUTION FOR LENS

K791523 · Pfizer, Inc. · Feb 1980

VISALENS CONCENTRATED CLEANER CONT LENS

K791524 · Pfizer, Inc. · Nov 1979

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 K810130

Optacryl, Inc.

Walker, MI · US

Regulatory profile

4 submissions 4 cleared

100% clearance rate · Active in Ophthalmic

View all devices by Optacryl, Inc. →

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: June 11, 1981. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: October 2026.

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