Cleared Special

K984575 - MULTI-PURPOSE DISINFECTING SOLUTION ID ...

K984575 is the FDA 510(k) clearance for MULTI-PURPOSE DISINFECTING SOLUTION ID ... by Alcon Laboratories. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Special 510(k) pathway after a 22-day FDA review.

K984575 · Alcon Laboratories · Ophthalmic device

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Jan 1999

Decision

22d

Days

Class 2

Risk

K984575 is an FDA 510(k) clearance for the MULTI-PURPOSE DISINFECTING SOLUTION ID 90746. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on January 14, 1999 after a review of 22 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 Alcon Laboratories devices

Submission Details

510(k) Number	K984575 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 23, 1998
Decision Date	January 14, 1999
Days to Decision	22 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

88d faster than avg

Panel avg: 110d · This submission: 22d

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 51

Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K984575.

OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER

K990480 · Alcon Laboratories · May 1999

RENU MULTIPLUS MULTI-PURPOSE SOLUTION

K990422 · Bausch & Lomb, Inc. · Apr 1999

BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER

K983225 · Bausch & Lomb, Inc. · Mar 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

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 K984575

Alcon Laboratories

Fort Worth, TX · US

RALPH H LARSEN

Regulatory profile

47 submissions 47 cleared

100% clearance rate · Active in Ophthalmic

Data Intelligence Layer

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