Cleared Traditional

K990480 - OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER

K990480 is the FDA 510(k) clearance for OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER by Alcon Laboratories. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K990480 · Alcon Laboratories · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
83d
Days
Class 2
Risk

K990480 is an FDA 510(k) clearance for the OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER. 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 May 10, 1999 after a review of 83 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

Submission Details

510(k) Number K990480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1999
Decision Date May 10, 1999
Days to Decision 83 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
27d faster than avg
Panel avg: 110d · This submission: 83d
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 K990480.
BAUSCH & LOMB RENU 1 STEP DAILY PROTEIN REMOVER
K000247 · Bausch & Lomb, Inc. · Apr 2000
OPTI-FREE EXPRESS MULTI-ACTION CLEANING AND REWETTING DROP
K984573 · Alcon Laboratories · Sep 1999
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K991403 · Ciba Vision Corporation · Jul 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
K984575 · Alcon Laboratories · Jan 1999