# K970019: Menicon Z Bifocal Design Lens/Menicon Z Trifocal Design Lens

- Pathway: 510(k) (Traditional)
- Applicant: Menicon U.S.A., Inc.
- Decided: Mar 25, 1997 after 82 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Spherical design lens of the Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens: named in the summary without a submission number

## Most influential descendants
- K103561: Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact Lens (2011), 0 descendants of its own

## Indications for use
The alternate designs of the Menicon Z (tisilfocon A) contact lens are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic and which may exhibit astigmatism of 3.00 Diopters (D) or less that does not interfere with visual acuity. The lens may be disinfected using a chemical disinfection only.

Source page: https://510kreport.com/device/K970019
Methodology: https://510kreport.com/methodology