Cleared Traditional

K890303 - OPTI-TEARS

K890303 is the FDA 510(k) clearance for OPTI-TEARS by Alcon Laboratories. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K890303 · Alcon Laboratories · Ophthalmic device
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Feb 1989
Decision
25d
Days
Class 2
Risk

K890303 is an FDA 510(k) clearance for the OPTI-TEARS(R). 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 February 17, 1989 after a review of 25 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 K890303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date February 17, 1989
Days to Decision 25 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 110d · This submission: 25d
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 K890303.
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
K974625 · Alcon Laboratories · Mar 1998
BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION
K973921 · Bausch & Lomb, Inc. · Jan 1998
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K973332 · Alcon Laboratories · Dec 1997
BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS
K874364 · Bausch & Lomb, Inc. · Nov 1987
OPTI-ZYME(R)
K873548 · Alcon Laboratories · Sep 1987
BAUSCH & LOMB CLEANING PAD
K843511 · Bausch & Lomb, Inc. · Oct 1986