Cleared Traditional

K830740 - CLERZ LUBRICATING & REWETTING EYE DROPS

K830740 · CooperVision, Inc. · Ophthalmic device

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Jun 1983

Decision

86d

Days

Risk

K830740 is an FDA 510(k) clearance for the CLERZ LUBRICATING & REWETTING EYE DROPS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on June 2, 1983 after a review of 86 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 - K830740

510(k) Number	K830740 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 08, 1983
Decision Date	June 02, 1983
Days to Decision	86 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

24d faster than avg

Panel avg: 110d · This submission: 86d

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 71

Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K830740.

HARD CONTACT LENS CASE

K831973 · Moonbeam International, Inc. · Oct 1983

SENSITIVE EYES

K832706 · Bausch & Lomb, Inc. · Oct 1983

HARD CONTACT LENS CLEANER

K832810 · Blairex Laboratories, Inc. · Sep 1983

GLISLENS

K823528 · Bio-Products, Inc. · Dec 1982

GFB-B CONTACT LENS BLANKS

K822315 · Hamel, Park, Mccabe & Saunders · Nov 1982

PRE-SERT

K822706 · Allergan, Inc. · Oct 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 K830740

CooperVision, Inc.

Southampton · GB

Regulatory profile

97 submissions 94 cleared

97% clearance rate · Active in Ophthalmic

View all devices by CooperVision, 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 2, 1983. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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