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.

FDA 510(k) Submission Details - K861643

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
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

77d faster than avg

Panel avg: 110d · This submission: 33d

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 K861643.

CHARTER LABORATORIES INC. LENS LUBRICANT

K863974 · Paco Pharmaceutical Services, Inc. · Nov 1986

CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES

K862952 · Paco Pharmaceutical Services, Inc. · Sep 1986

AQUALUX LENS CASE

K862811 · Safeway Products, Inc. · Sep 1986

EASY EYES TM LENS CARRYING CASE

K860677 · Applied Laboratories, Inc. · May 1986

LENSKEEPER CONTACT LENS CARRYING CASE

K861642 · Allergan, Inc. · May 1986

WETTING & SOAKING HARD CONTACT LENS SOLUTION

K861712 · Maurry Biological Co. · May 1986

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 K861643

Allergan, Inc.

Irvine, CA · US

MARVIN J GARRETT

Regulatory profile

33 submissions 33 cleared

100% clearance rate · Active in Ophthalmic

View all devices by Allergan, 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, 1986. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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