Cleared Traditional

K971618 - ALCON CONTACT LENS CASE

K971618 is the FDA 510(k) clearance for ALCON CONTACT LENS CASE by Alcon Laboratories. It is a Class 2 Ophthalmic device (product code LRX) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K971618 · Alcon Laboratories · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
73d
Days
Class 2
Risk

K971618 is an FDA 510(k) clearance for the ALCON CONTACT LENS CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on July 14, 1997 after a review of 73 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 K971618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1997
Decision Date July 14, 1997
Days to Decision 73 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
37d faster than avg
Panel avg: 110d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRX Case, Contact Lens
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 - LRX Case, Contact Lens

All 11
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K971618.
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820 · Ciba Vision Corporation · Sep 2005
CYBERCASES BY BAUSCH & LOMB
K013232 · Bausch & Lomb, Inc. · Nov 2001
ALCON CONTACT LENS CASE
K974281 · Alcon Laboratories · Jan 1998
CIBA VISION(R) CONTACT LENS CASE
K943183 · Ciba Vision Corporation · Aug 1994
OPTI-FREE CONTACT LENS CASE
K931620 · Alcon Laboratories · Jun 1993
BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM
K896685 · Bausch & Lomb, Inc. · Dec 1989