510(k) · Cleared
ClearedTyro 97 (Hofocon a) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses for Daily Wear
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 Nov 2, 2005 after a 50-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Nov 2, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK052507 Tyro 97 (Hofocon a) Rigid Gas Permeable Spherical, Aspheric, Toric…The Lagado Corp. · 2005
- 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 |
|---|---|---|---|---|---|
| 0 (this device) | K052507 | Tyro 97 (Hofocon a) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal… | The Lagado Corp. | 2005 | — |
| +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 | — |
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 |
|---|---|---|---|
| * | — | Oxycon (wilofocon A) Rigid Gas Permeable Contact Lenses Named without a submission number |
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?
- Of its descendants, K230965 (Acuity Polymers, Inc., 2023) has gone furthest, with 4 descendants of its own.
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.
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 TYROTM-97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal 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 comeal astigmatism.
The lenses may be disinfected only by using chemical disinfection
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052507: Tyro 97 (Hofocon a) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact Lenses for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052507
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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