510(k) · Cleared
ClearedAcuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acuity Polymers, Inc. · HQD Lens, Contact (Other Material) - Daily
Cleared on Jun 16, 2023 as substantially equivalent to K162005 (Acuity Polymers, Inc., 2016) and 4 other predicates after a 72-day review. Its family tree reaches back 9 generations to 1994. 4 later devices descend from it.
- Decided
- Jun 16, 2023
- Review
- 72 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K943177 (1994). 29 ancestors in all, the oldest P860022 (1987). 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- 5 generations between
- 3 generations backK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
- 2 generations backK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
- 1 generation backK183167 Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO…Bausch & Lomb, Incorporated · 2019
- This deviceK230965 Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97…Acuity Polymers, Inc. · 2023
- Descendant · cites it directly · 3 of its ownK240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens…Acuity Polymers, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK242393 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with…Acuity Polymers, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK241398 SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK241571 BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight · 2024
Show all 9 generations
- Root · 9 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- 8 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- 7 generations backK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
- 6 generations backK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
- 5 generations backK071266 Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · Recalled
- 4 generations backK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
- 3 generations backK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
- 2 generations backK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
- 1 generation backK183167 Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO…Bausch & Lomb, Incorporated · 2019
- This deviceK230965 Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97…Acuity Polymers, Inc. · 2023
Most influential descendants
Showing 4 of 4 · See all- K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon…Acuity Polymers, Inc. · 2024 · cites it directly3descendants
- K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG®…Acuity Polymers, Inc. · 2024 · 2 generations on0descendants
- K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd. · 2024 · 2 generations on0descendants
- K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | 1 |
| −8 | K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| −7 | K020006 | Dyna Intra-Limbal Lens | Lens Dynamics, Inc. | 2002 | — |
| −6 | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)… | Bausch & Lomb, Incorporated | 2006 | — |
| −5 | K071266 | Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens | Bausch & Lomb, Inc. | 2007 | 2 |
| −4 | K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | Boston Foundation For Sight | 2016 | — |
| −3 | K161461 | BostonSight PD Prosthetic Device | Bostonsight | 2016 | 1 |
| −2 | K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | Bausch + Lomb, Incorporated | 2017 | — |
| −1 | K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO… | Bausch & Lomb, Incorporated | 2019 | — |
| 0 (this device) | K230965 | Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with… | Acuity Polymers, Inc. | 2023 | — |
| +1 | K240618 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™… | Acuity Polymers, Inc. | 2024 | — |
| +2 | K242393 | Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™… | Acuity Polymers, Inc. | 2024 | — |
| +2 | K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | Tianjin Mastervision Technology Co., Ltd. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K162005 | Acuity 100 (hexafocon A) Rigid Gas Permeable Contact LensSummary page 5…dra-PEG® Purpose of the 510(k) Submission: Acuity 100™ (hexafocon A) and TYRO™-97 (hofocon A) Rigid Gas Permeable Contact Lenses, cleared under 510(k) K162005, K180988, K052507 and K102154 are modified to include Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene g… | 2016 |
| * | K180988 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B)…Summary page 5…Purpose of the 510(k) Submission: Acuity 100™ (hexafocon A) and TYRO™-97 (hofocon A) Rigid Gas Permeable Contact Lenses, cleared under 510(k) K162005, K180988, K052507 and K102154 are modified to include Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PE… | 2018 |
| * | K052507 | Tyro 97 (Hofocon a) Rigid Gas Permeable Spherical, Aspheric, Toric and Bifocal Contact…Summary page 5…rpose of the 510(k) Submission: Acuity 100™ (hexafocon A) and TYRO™-97 (hofocon A) Rigid Gas Permeable Contact Lenses, cleared under 510(k) K162005, K180988, K052507 and K102154 are modified to include Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based… | 2005 |
| * | K102154 | Tyro-97 (Hofocon a), Onsi 56 (Hofocon), Rigid Gas Permeable Spherical, Aspheric, Toric…Summary page 5…510(k) Submission: Acuity 100™ (hexafocon A) and TYRO™-97 (hofocon A) Rigid Gas Permeable Contact Lenses, cleared under 510(k) K162005, K180988, K052507 and K102154 are modified to include Tangible™ Hydra-PEG® surface coating, which is a thin, polyethylene glycol (PEG) based polymer… | 2011 |
| * | K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)…Summary page 5…ate device: Boston XO® (hexafocon A) Rigid Gas Permeable Contact Lenses with Tangible™ Hydra- PEG Rigid Gas Permeable Contact Lenses, 510(k) number K183167. IV. DEVICE DESCRIPTION Acuity 100™ (hexafocon A) are available as lathe cut rigid gas permeable contact lenses for… | 2019 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240618 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon… | 2024 | 3 |
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 29 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 28 ancestors have a recall of any class.
- Of its descendants, K240618 (Acuity Polymers, Inc., 2024) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K162005.
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. 2023, 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?
Acuity™ 100 (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact 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. 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…
Read the full statement (176 words)
Acuity™ 100 (hexafocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact 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. 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 disinfected using a chemical disinfection system only.
TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in non-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/K230965 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230965: Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® 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/K230965
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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