Cleared Special

K984383 - ULTRACARE NEUTRALIZING TABLETS

K984383 is the FDA 510(k) clearance for ULTRACARE NEUTRALIZING TABLETS by Allergan, Inc.. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Special 510(k) pathway after a 10-day FDA review.

K984383 · Allergan, Inc. · Ophthalmic device

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Dec 1998

Decision

10d

Days

Class 2

Risk

K984383 is an FDA 510(k) clearance for the ULTRACARE NEUTRALIZING TABLETS. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Allergan, Inc. (Irvine, US). The FDA issued a Cleared decision on December 18, 1998 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Allergan, Inc. devices

Submission Details

510(k) Number	K984383 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 08, 1998
Decision Date	December 18, 1998
Days to Decision	10 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

100d faster than avg

Panel avg: 110d · This submission: 10d

Pathway characteristics

Modification to existing cleared device.

Device Classification

Product Code	LPN Accessories, Soft Lens Products
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 886.5928

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - LPN Accessories, Soft Lens Products

All 52

Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K984383.

MULTI-PURPOSE DISINFECTING SOLUTION ID 90746

K984575 · Alcon Laboratories · Jan 1999

MULTI-PURPOSE DISINFECTING SOLUTION ID 90746

K983780 · Alcon Laboratories · Dec 1998

OPTI-ONE MULTI-PURPOSE SOLUTION

K983973 · Alcon Laboratories · Dec 1998

SOLO-CARE BRAND MULTI-PURPOSE SOLUTION

K982168 · Ciba Vision Corporation · Nov 1998

BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION

K982775 · Bausch & Lomb, Inc. · Nov 1998

LIQUID ENZYME ID 90133

K981561 · Alcon Laboratories · Jul 1998

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 K984383

Allergan, Inc.

Irvine, CA · US

PAUL J NOWACKI

Regulatory profile

33 submissions 33 cleared

100% clearance rate · Active in Ophthalmic

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