Cleared Traditional

K981561 - LIQUID ENZYME ID 90133

K981561 is an FDA 510(k) clearance for LIQUID ENZYME ID 90133, 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 84-day FDA review.

K981561 · Alcon Laboratories · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
84d
Days
Class 2
Risk

K981561 is an FDA 510(k) clearance for the LIQUID ENZYME ID 90133. 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 July 24, 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

FDA 510(k) Submission Details - K981561

510(k) Number K981561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1998
Decision Date July 24, 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.

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 K981561.
SOLO-CARE BRAND MULTI-PURPOSE SOLUTION
K982168 · Ciba Vision Corporation · Nov 1998
BAUSCH & LOMB RENU MULTI-PURPOSE SOLUTION
K982775 · Bausch & Lomb, Inc. · Nov 1998
COMPLETE BRAND MULTI-PURPOSE SOLUTION, COMPLETE BRAND LUBRICATING AND REWETTING DROPS
K981168 · Allergan, Inc. · Sep 1998
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K980775 · Allergan, Inc. · Jul 1998
OPTI-FREE EXPRESS MULTI-PURPOSE SOLUTION
K981574 · Alcon · Jul 1998
RENU MULTIPLUS LUBRICATING & REWETTING DROPS
K980591 · Bausch & Lomb, Inc. · Jun 1998