Cleared Traditional

K820817 - OPTACRY/95 GRAY CONTACT LENS BLANKS

K820817 · Optacryl, Inc. · Ophthalmic device

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May 1982

Decision

42d

Days

Risk

K820817 is an FDA 510(k) clearance for the OPTACRY/95 GRAY CONTACT LENS BLANKS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Optacryl, Inc. (Walker, US). The FDA issued a Cleared decision on May 5, 1982 after a review of 42 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 - K820817

510(k) Number	K820817 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 24, 1982
Decision Date	May 05, 1982
Days to Decision	42 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

68d faster than avg

Panel avg: 110d · This submission: 42d

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 K820817.

BLINK-N-CLEAN

K821055 · Allergan, Inc. · May 1982

OPTACRY/95 BLUE CONTACT LENS BLANKS

K820815 · Optacryl, Inc. · May 1982

OPTACRY/ 95 GREEN CONTACT LENS BLANKS

K820816 · Optacryl, Inc. · May 1982

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

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 K820817

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: May 5, 1982. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: November 2026.

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