# K962006: Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Menicon Co, Ltd.
- Decided: Oct 9, 1996 after 140 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- 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) Menicon SF-P™ (melafocon 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 Menicon Z™ Rigid Gas Permeable Contact Lens for Daily Wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes who are myopic or hyperopic and have an astigmatism of up to 3.00 Diopters (D) that does not interfere with visual acuity. The lens may be disinfected using a chemical disinfection only.

Source page: https://510kreport.com/device/K962006
Methodology: https://510kreport.com/methodology