510(k) · Cleared
ClearedMenicon Z (Tisilfocon a) Rigid Gas Permeable Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Menicon Co, Ltd. · HQD Lens, Contact (Other Material) - Daily
Cleared on Feb 3, 2011 as substantially equivalent to K962006 (Menicon Co, Ltd., 1996) and 5 other predicates after a 59-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Feb 3, 2011
- Review
- 59 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 6 generations to K943177 (1994). 17 ancestors in all, the oldest P860022 (1987). No later device cites it as a predicate yet.
- Root · 6 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- 5 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- 4 generations backK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
- 3 generations backK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
- 2 generations backK071043 Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES…Bausch & Lomb, Inc. · 2007 · Recalled
- 1 generation backK081443 Menicon Z Rigid Gas Permeable Contact LensMenicon Co, Ltd. · 2008
- This deviceK103561 Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact LensMenicon Co, Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | 1 |
| −5 | K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| −4 | K020006 | Dyna Intra-Limbal Lens | Lens Dynamics, Inc. | 2002 | — |
| −3 | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)… | Bausch & Lomb, Incorporated | 2006 | — |
| −2 | K071043 | Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a)… | Bausch & Lomb, Inc. | 2007 | 2 |
| −1 | K081443 | Menicon Z Rigid Gas Permeable Contact Lens | Menicon Co, Ltd. | 2008 | — |
| 0 (this device) | K103561 | Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact Lens | Menicon Co, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HQD device
- #1 K240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas…score 19.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K962006 | Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact LensSummary page 1…al equivalence of the Menicon ZTM (tisilfocon A) to the following predicate devices. I . Menicon Z TM (tisilfocon A) Rigid Gas Permeable Contact Lenses (K962006, K970019, K08 1443) 2. Boston X0 2 (hexafocon B) Rigid Gas Permeable Contact Lenses (K071266)… | 1996 |
| * | K970019 | Menicon Z Bifocal Design Lens/Menicon Z Trifocal Design LensSummary page 1…icon ZTM (tisilfocon A) to the following predicate devices. I . Menicon Z TM (tisilfocon A) Rigid Gas Permeable Contact Lenses (K962006, K970019, K08 1443) 2. Boston X0 2 (hexafocon B) Rigid Gas Permeable Contact Lenses (K071266) 3. Boston XO (hexafo… | 1997 |
| * | K081443 | Menicon Z Rigid Gas Permeable Contact LensSummary page 1…(tisilfocon A) to the following predicate devices. I . Menicon Z TM (tisilfocon A) Rigid Gas Permeable Contact Lenses (K962006, K970019, K08 1443) 2. Boston X0 2 (hexafocon B) Rigid Gas Permeable Contact Lenses (K071266) 3. Boston XO (hexafocon A) Rig… | 2008 |
| * | K071266 | Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensSummary page 1…isilfocon A) Rigid Gas Permeable Contact Lenses (K962006, K970019, K08 1443) 2. Boston X0 2 (hexafocon B) Rigid Gas Permeable Contact Lenses (K071266) 3. Boston XO (hexafocon A) Rigid Gas Permeable Contact Lenses (K071043) 4. Boston Equalens 11 (oprifocon… | 2007 |
| * | K071043 | Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a) Rigid Gas…Summary page 1…08 1443) 2. Boston X0 2 (hexafocon B) Rigid Gas Permeable Contact Lenses (K071266) 3. Boston XO (hexafocon A) Rigid Gas Permeable Contact Lenses (K071043) 4. Boston Equalens 11 (oprifocon A) (K022128) (Rigid Gas Permeable Contact Lenses 4. Description of de… | 2007 |
| * | K022128 | Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact LensSummary page 1…as Permeable Contact Lenses (K071266) 3. Boston XO (hexafocon A) Rigid Gas Permeable Contact Lenses (K071043) 4. Boston Equalens 11 (oprifocon A) (K022128) (Rigid Gas Permeable Contact Lenses 4. Description of device The Menicon ZTM lens material, tisilfocon A is… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 16 ancestors have a recall of any class.
How does its category compare?
All HQD devicesHQD Lens, Contact (Other Material) - Daily: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HQD
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HQD
80in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQD
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQD
2in 2025
MAUDE reports naming product code HQD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 78 | 0 | 6 |
| 2008 | 5 | 100 | 0 | 8 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 1 | — | 0 | 26 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 7 | 119 | 0 | 1 |
| 2017 | 9 | 66 | 0 | 3 |
| 2018 | 5 | 53 | 0 | 0 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 3 | 123 | 0 | 3 |
| 2022 | 3 | 29 | 0 | 3 |
| 2023 | 3 | 77 | 0 | 8 |
| 2024 | 5 | 80 | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (211 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103561 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103561: Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103561
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026