# K081443: Menicon Z Rigid Gas Permeable Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Menicon Co, Ltd.
- Decided: Sep 23, 2008 after 124 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
Longest line of descent: 5 generations back to K943177 (1994). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013646: Rose K Post Graft Lens, Rose K International, Ltd. (2002) Summary page 1.
- K020006: Dyna Intra-Limbal Lens, Lens Dynamics, Inc. (2002) Summary page 1.
- K013762: Rigid Gas Permeable Contact Lens, Bausch & Lomb, Incorporated (2002) Summary page 1.
- K053124: Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas Permeable Contact Lenses, Bausch & Lomb, Incorporated (2006) Summary page 1.
- K071043: Boston XO (Hexafocon a), Boston EO (Enflufocon B)  and Boston ES (Enflufocon a) Rigid Gas Permeable Contact Lenses, Bausch & Lomb, Inc. (2007) Summary page 1.

## 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 (tisilfocon A) Rigid Gas Permeable Contact Lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic or not-aphakic persons with non-diseased eyes. The lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K081443
Methodology: https://510kreport.com/methodology