Cleared Traditional

K843342 - LENSKEEPER LENS CARRYING CASE

K843342 · Allergan Pharmaceuticals, Inc. · Ophthalmic device

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Nov 1984

Decision

84d

Days

Risk

K843342 is an FDA 510(k) clearance for the LENSKEEPER LENS CARRYING CASE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Allergan Pharmaceuticals, Inc. (Irvine, US). The FDA issued a Cleared decision on November 19, 1984 after a review of 84 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 Allergan Pharmaceuticals, Inc. devices

Submission Details

510(k) Number	K843342 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 27, 1984
Decision Date	November 19, 1984
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

26d faster than avg

Panel avg: 110d · This submission: 84d

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 K843342.

LENSKEEPER CONTACT LENS CARRYING CASE

K861642 · Allergan, Inc. · May 1986

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

CLERZ LUBRICATING & REWETTING EYE DROPS

K830740 · CooperVision, Inc. · Jun 1983

PRE-SERT

K822706 · Allergan, Inc. · Oct 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 K843342

Allergan Pharmaceuticals, Inc.

Irvine, CA · US

MARVIN J GARRETT

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.

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