Cleared Traditional

K970019 - MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS

K970019 is an FDA 510(k) clearance for MENICON Z BIFOCAL DESIGN LENS/MENICON Z..., manufactured by Menicon U.S.A., Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K970019 · Menicon U.S.A., Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
82d
Days
Class 2
Risk

K970019 is an FDA 510(k) clearance for the MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Menicon U.S.A., Inc. (Washington, US). The FDA issued a Cleared decision on March 25, 1997 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - 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 Menicon U.S.A., Inc. devices

FDA 510(k) Submission Details - K970019

510(k) Number K970019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1997
Decision Date March 25, 1997
Days to Decision 82 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
28d faster than avg
Panel avg: 110d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
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 - LPL Lenses, Soft Contact, Daily Wear

All 191
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K970019.
SEE3 (LOTRAFILCON A) SOFT CONTACT LENS
K970746 · Ciba Vision Corporation · May 1997
PROCLEAR COMPATIBLES DAILY WEAR CONTACT LENS
K970095 · Biocompatibles Eyewear, Inc. · Apr 1997
CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)
K970312 · Flexlens, Inc. · Apr 1997
PROMED 55-G SOFT DAILY WEAR CONTACT LENS
K970615 · Biomed Devices Corp. · Mar 1997
CONTACT LENSES METRO-G 3X (HIOXIFILCON B)
K964902 · Metro Optics of Austin, Inc. · Mar 1997
LIFESTYLE BREAK THRU (POLYMACON)
K965012 · The Lifestyle Co., Inc. · Mar 1997