Cleared Traditional

K943183 - CIBA VISION(R) CONTACT LENS CASE

K943183 is an FDA 510(k) clearance for CIBA VISION CONTACT LENS CASE, manufactured by Ciba Vision Corporation. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K943183 · Ciba Vision Corporation · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
34d
Days
Class 2
Risk

K943183 is an FDA 510(k) clearance for the CIBA VISION(R) CONTACT LENS CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Ciba Vision Corporation (Duluth, US). The FDA issued a Cleared decision on August 4, 1994 after a review of 34 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.

FDA 510(k) Submission Details - K943183

510(k) Number K943183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1994
Decision Date August 04, 1994
Days to Decision 34 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
76d faster than avg
Panel avg: 110d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRX Device Classification - Class 2, Special Controls

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 67
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K943183.
MENICON SP VIAL
K950878 · Hyman, Phelps & McNamara, P.C. · Apr 1995
DATEMINDER CONTACT LENS CASE
K945259 · Bruce A. Berkley · Jan 1995
RYDER CONTACT LENS CASE
K943921 · Clinical Research Assoc. · Oct 1994
OPTI-FREE CONTACT LENS CASE
K931620 · Alcon Laboratories · Jun 1993
CONTACT LENS CASE
K923458 · Nomax, Inc. · May 1993
OPTI-LENS CONTACT LENS CASE
K920064 · Ryder Intl. Corp. · Mar 1992
K943183 · CIBA VISION(R) CONTACT LENS CASE
Download PDF FDA Summary Ciba Vision Corporati…