Cleared Traditional

K981151 - OPTI-FREE SUPRACLENS DAILY PROTEIN REMO...

K981151 is the FDA 510(k) clearance for OPTI-FREE SUPRACLENS DAILY PROTEIN REMO... by Alcon Laboratories. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K981151 · Alcon Laboratories · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
84d
Days
Class 2
Risk

K981151 is an FDA 510(k) clearance for the OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER/ALCON WETTING, SOAKING, CONDITIONI.... 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 June 22, 1998 after a review of 84 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 K981151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1998
Decision Date June 22, 1998
Days to Decision 84 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
26d faster than avg
Panel avg: 110d · This submission: 84d
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 K981151.
BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION
K982775 · Bausch & Lomb, Inc. · Nov 1998
LIQUID ENZYME ID 90133
K981561 · Alcon Laboratories · Jul 1998
RENU MULTIPLUS LUBRICATING & REWETTING DROPS
K980591 · Bausch & Lomb, Inc. · Jun 1998
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K974723 · Bausch & Lomb, Inc. · Mar 1998
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K974624 · Alcon Laboratories · Mar 1998
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
K974625 · Alcon Laboratories · Mar 1998