Cleared Traditional

K983973 - OPTI-ONE MULTI-PURPOSE SOLUTION

K983973 is an FDA 510(k) clearance for OPTI-ONE MULTI-PURPOSE SOLUTION, 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 39-day FDA review.

K983973 · Alcon Laboratories · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
39d
Days
Class 2
Risk

K983973 is an FDA 510(k) clearance for the OPTI-ONE MULTI-PURPOSE SOLUTION. 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 December 18, 1998 after a review of 39 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alcon Laboratories devices

FDA 510(k) Submission Details - K983973

510(k) Number K983973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1998
Decision Date December 18, 1998
Days to Decision 39 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
71d faster than avg
Panel avg: 110d · This submission: 39d
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 K983973.
LOBOB UNIVERSAL CONTACT LENS CLEANER
K990044 · Lobob Laboratories, Inc. · Feb 1999
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K984575 · Alcon Laboratories · Jan 1999
MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K983780 · Alcon Laboratories · Dec 1998
ULTRACARE NEUTRALIZING TABLETS
K984383 · Allergan, Inc. · Dec 1998
COMPLETE BRAND LUBRICATING AND REWETTING DROPS
K983150 · Allergan, Inc. · Nov 1998
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K982168 · Ciba Vision Corporation · Nov 1998