Cleared Traditional

K984573 - OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP

K984573 is an FDA 510(k) clearance for OPTI-FREE EXPRESS MULTI-ACTION CLEANING..., manufactured by Alcon Laboratories. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K984573 · Alcon Laboratories · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
267d
Days
Class 2
Risk

K984573 is an FDA 510(k) clearance for the OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP. 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 September 16, 1999 after a review of 267 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Alcon Laboratories devices

FDA 510(k) Submission Details - K984573

510(k) Number K984573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1998
Decision Date September 16, 1999
Days to Decision 267 days
Submission Type Traditional
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
157d slower than avg
Panel avg: 110d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 82
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K984573.
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
K000247 · Bausch & Lomb, Inc. · Apr 2000
REFRESH CONTACTS LUBRICATING AND REWETTING DROPS
K992028 · Allergan, Inc. · Oct 1999
VISINE FOR CONTACTS
K991620 · Pfizer, Inc. · Sep 1999
SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES
K991125 · Sauflon Pharmaceuticals, Ltd. · Sep 1999
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K991403 · Ciba Vision Corporation · Jul 1999
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
K990480 · Alcon Laboratories · May 1999