Cleared Traditional

K984573 - OPTI-FREE EXPRESS MULTI-ACTION CLEANING...

K984573 is the FDA 510(k) clearance for OPTI-FREE EXPRESS MULTI-ACTION CLEANING... by Alcon Laboratories. It is a Class 2 Ophthalmic device (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

Submission Details

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.

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 K984573.
RENU MULTIPLUS MULTI-PURPOSE DISINFECTING SOLUTION
K002823 · Bausch & Lomb, Inc. · Oct 2000
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K001539 · Bausch & Lomb, Inc. · Jul 2000
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
K000247 · Bausch & Lomb, Inc. · Apr 2000
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K991403 · Ciba Vision Corporation · Jul 1999
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
K990480 · Alcon Laboratories · May 1999
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K990422 · Bausch & Lomb, Inc. · Apr 1999