510(k) · Cleared
ClearedTyro-97 (Hofocon a), Onsi 56 (Hofocon), Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Lagado Corp. · HQD Lens, Contact (Other Material) - Daily
Cleared on Jan 21, 2011 as substantially equivalent to K053124 (Bausch & Lomb, Incorporated, 2006) after a 175-day review. Its family tree reaches back 4 generations to 1994. 5 later devices descend from it.
- Decided
- Jan 21, 2011
- Review
- 175 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943177 (1994). 5 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- 3 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- 2 generations backK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
- 1 generation backK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
- This deviceK102154 Tyro-97 (Hofocon a), Onsi 56 (Hofocon), Rigid Gas Permeable…The Lagado Corp. · 2011
- Descendant · cites it directly · 4 of its ownK230965 Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97…Acuity Polymers, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens…Acuity Polymers, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK242393 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with…Acuity Polymers, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK241398 SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK241571 BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight · 2024
Most influential descendants
Showing 5 of 5 · See all- K230965Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™…Acuity Polymers, Inc. · 2023 · cites it directly4descendants
- K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon…Acuity Polymers, Inc. · 2024 · 2 generations on3descendants
- K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG®…Acuity Polymers, Inc. · 2024 · 3 generations on0descendants
- K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd. · 2024 · 3 generations on0descendants
- K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | 1 |
| −3 | K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| −2 | K020006 | Dyna Intra-Limbal Lens | Lens Dynamics, Inc. | 2002 | — |
| −1 | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)… | Bausch & Lomb, Incorporated | 2006 | — |
| 0 (this device) | K102154 | Tyro-97 (Hofocon a), Onsi 56 (Hofocon), Rigid Gas Permeable Spherical… | The Lagado Corp. | 2011 | — |
| +1 | K230965 | Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with… | Acuity Polymers, Inc. | 2023 | — |
| +2 | K240618 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™… | Acuity Polymers, Inc. | 2024 | — |
| +3 | K242393 | Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™… | Acuity Polymers, Inc. | 2024 | — |
| +3 | K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | Tianjin Mastervision Technology Co., Ltd. | 2024 | — |
| +3 | K241571 | BostonSight® Specialty Lenses | Boston Foundation For Sight, Inc. D/B/A Bostonsight | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 4 | 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? (1)
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 |
|---|---|---|---|
| * | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas…Summary page 3…e management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery K053 124 - SE Decision Date 30-JAN-06.… | 2006 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230965 | Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™… | 2023 | 4 |
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 5 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K230965 (Acuity Polymers, Inc., 2023) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K053124.
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?
The TYRO TM -97 (hofocon A) and ONSI Th -56 (onsifocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic or presbyopic and which may exhibit corneal astigmatism. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable 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 only by using chemical disinfection
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102154: Tyro-97 (Hofocon a), Onsi 56 (Hofocon), Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal 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/K102154
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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