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.

View all CooperVision, Inc. devices

Submission Details

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.

Device Classification

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

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 7

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

BAUSCH & LOMB LENS CARRYING CASE

K854968 · Bausch & Lomb, Inc. · Apr 1986

SIGHT SAVER ALL PURPOSE LENS CARRYING CASE

K852384 · Bausch & Lomb, Inc. · Jul 1985

SENSITIVE EYES

K832706 · Bausch & Lomb, Inc. · Oct 1983

BAUSCH & LOMB STERILE ALL PURPOSE SOLU

K820511 · Bausch & Lomb, Inc. · Apr 1982

CONCENTRATED CLEANER FOR HARD CONTACTS

K820818 · Bausch & Lomb, Inc. · Apr 1982

LENSINE EXTRA STRENGTH CLEANER

K812433 · CooperVision, Inc. · Sep 1981

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 K830740

CooperVision, Inc.

Southampton · GB

Regulatory profile

97 submissions 94 cleared

97% 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.

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