510(k) · Cleared
ClearedBoston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas Permeable Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Incorporated · HQD Lens, Contact (Other Material) - Daily
Cleared on Jan 30, 2006 as substantially equivalent to K020006 (Lens Dynamics, Inc., 2002) and 1 other predicate after an 84-day review. Its family tree reaches back 3 generations to 1994. 38 later devices descend from it.
- Decided
- Jan 30, 2006
- Review
- 84 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K943177 (1994). 4 ancestors in all. 38 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- 2 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- 1 generation backK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
- This deviceK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
- Descendant · cites it directly · 26 of its ownK071266 Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 20 of its ownK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
- Descendant · 3 generations on · 19 of its ownK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
- Descendant · 4 generations on · 14 of its ownK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
- Descendant · cites it directly · 14 of its ownK071043 Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES…Bausch & Lomb, Inc. · 2007 · Recalled
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K071266Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · cites it directly26descendants
- K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016 · 2 generations on20descendants
- K161461BostonSight PD Prosthetic DeviceBostonsight · 2016 · 3 generations on19descendants
- K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017 · 4 generations on14descendants
- K071043Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a) Rigid Gas…Bausch & Lomb, Inc. · 2007 · cites it directly14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | 1 |
| −2 | K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| −1 | K020006 | Dyna Intra-Limbal Lens | Lens Dynamics, Inc. | 2002 | — |
| 0 (this device) | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)… | Bausch & Lomb, Incorporated | 2006 | — |
| +1 | K071266 | Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens | Bausch & Lomb, Inc. | 2007 | 2 |
| +2 | K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | Boston Foundation For Sight | 2016 | — |
| +3 | K161461 | BostonSight PD Prosthetic Device | Bostonsight | 2016 | 1 |
| +4 | K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | Bausch + Lomb, Incorporated | 2017 | — |
| +1 | K071043 | Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a)… | Bausch & Lomb, Inc. | 2007 | 2 |
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 |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2016 | 6 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K020006 | Dyna Intra-Limbal LensSummary page 1…TE DEVICES Lens Dynamics Inc., Dyna Intra-Limbal Lens (enflufocon A or hexafocon A) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premnarket Notification K020006, and Rose K Post Graft (hexafocon A or enflufocon B) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premnarket Notificati… | 2002 |
| * | K013646 | Rose K Post Graft LensSummary page 1…k) Premnarket Notification K020006, and Rose K Post Graft (hexafocon A or enflufocon B) Rigid Gas Permeable Contact Lens, cleared in 510(k) Premnarket Notification K013646, have been selected as the predicate devices for the BOSTON ES (enflufocon A), BOSTON EO (enflufocon B), and BOSTON XO (hex… | 2002 |
What descends from it? (38)
See all 388 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071266 | Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens | 2007 | 26 |
| K071043 | Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a) Rigid Gas… | 2007 | 14 |
| K070628 | Optimum GP (Roflufocon a,B,C,D&E) Daily Wear Contact Lens. | 2007 | 10 |
| K183167 | Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B)… | 2019 | 5 |
| K102154 | Tyro-97 (Hofocon a), Onsi 56 (Hofocon), Rigid Gas Permeable Spherical, Aspheric, Toric… | 2011 | 5 |
| K120996 | Fluoroperm 30 Paragon HDS Fluoroperm 60 Paragon HDS 100 Fluoroperm 92 Fluoroperm 151… | 2012 | 1 |
| K081443 | Menicon Z Rigid Gas Permeable Contact Lens | 2008 | 1 |
| K163254 | Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens | 2017 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K071266 (Bausch & Lomb, Inc., 2007) has gone furthest, with 26 descendants of its own.
- 2 other devices also cite its predicate K020006.
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 BOSTON ES® (enflufocon A), BOSTON EO® (enflufocon B) and BOSTON XO® (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic and not-aphakic persons with non-diseased eyes. Also, the lenses may be prescribed 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 lenses may be disinfected using a chemical disinfection system only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053124 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053124: Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas Permeable Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053124
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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