# K972443: Menicon SF-P and Menicon Z Rigid Gas Permeable Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Menicon U.S.A., Inc.
- Decided: Aug 22, 1997 after 53 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.
No later device cites it as a predicate yet.
0 of 1 device 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 under dry storage: named in the summary without a submission number
- (no number) Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lens under dry storage: named in the summary without a submission number

## Indications for use
The Menicon SF-P (melafocon A) Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only. The Menicon Z (tisilfocon A) Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K972443
Methodology: https://510kreport.com/methodology