Cleared Traditional

K861643 - STYLEKEEPER CONTACT LENS CARRYING CASE

K861643 · Allergan, Inc. · Ophthalmic device

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Jun 1986

Decision

33d

Days

Risk

K861643 is an FDA 510(k) clearance for the STYLEKEEPER CONTACT LENS CARRYING CASE. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on June 2, 1986 after a review of 33 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, Inc. devices

Submission Details

510(k) Number	K861643 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 30, 1986
Decision Date	June 02, 1986
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

77d faster than avg

Panel avg: 110d · This submission: 33d

Pathway characteristics

Predicate-based equivalence.

Device Classification

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

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 8

Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K861643.

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

BAUSCH & LOMB STERILE ALL PURPOSE SOLU

K820511 · Bausch & Lomb, Inc. · Apr 1982

CONCENTRATED CLEANER FOR HARD CONTACTS

K820818 · Bausch & Lomb, Inc. · Apr 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 K861643

Allergan, Inc.

Irvine, CA · US

MARVIN J GARRETT

Regulatory profile

33 submissions 33 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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