Cleared Special

K984575 - MULTI-PURPOSE DISINFECTING SOLUTION ID 90746

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

K984575 · Alcon Laboratories · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K984575

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.

LPN Device Classification - Class 2, Special Controls

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 120
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K984575.
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
LOBOB UNIVERSAL CONTACT LENS CLEANER
K990044 · Lobob Laboratories, Inc. · Feb 1999
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K983780 · Alcon Laboratories · Dec 1998
OPTI-ONE MULTI-PURPOSE SOLUTION
K983973 · Alcon Laboratories · Dec 1998
ULTRACARE NEUTRALIZING TABLETS
K984383 · Allergan, Inc. · Dec 1998
K984575 · MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
Download PDF FDA Summary Alcon Laboratories