# K103561: Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Menicon Co, Ltd.
- Decided: Feb 3, 2011 after 59 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: 6 generations back to K943177 (1994). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962006: Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact Lens, Menicon Co, Ltd. (1996) Summary page 1.
- K970019: Menicon Z Bifocal Design Lens/Menicon Z Trifocal Design Lens, Menicon U.S.A., Inc. (1997) Summary page 1.
- K081443: Menicon Z Rigid Gas Permeable Contact Lens, Menicon Co, Ltd. (2008) Summary page 1.
- K071266: Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens, Bausch & Lomb, Inc. (2007) 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.
- K022128: Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens, Bausch & Lomb, Incorporated (2002) Summary page 1.

## Indications for use
Menicon ZTM (tisilfocon A) spherical, aspheric, prism ballast toric and prism ballast multifocal lenses are 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. Menicon ZTM (tisilfocon A) spherical, aspheric, non-prism ballast toric and non-prism ballast multifocal corneal lenses are indicated for extended wear (from 1 to 30 days between removals for cleaning and disinfection of the lenses, as recommended by the eyecare professional) for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear 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 lens may be prescribed in spherical and aspheric powers ranging from -25.00 D to +25.00 D for daily wear and -25.00 D to +8.00 D for up to 30 days extended wear. Toric lenses are designed to correct up to 5.00 D of astigmatism and multifocal lenses to provide up to +3.00 D of reading add power for up to 30 days extended wear. The lens may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K103561
Methodology: https://510kreport.com/methodology