510(k) · Cleared
Recalled · Class II · 2025BostonSight PD Prosthetic Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bostonsight · HQD Lens, Contact (Other Material) - Daily
Cleared on Jul 25, 2016 as substantially equivalent to K153066 (Boston Foundation For Sight, 2016) and 1 other predicate after a 60-day review. Its family tree reaches back 6 generations to 1994. 19 later devices descend from it. It has been recalled once.
- Decided
- Jul 25, 2016
- Review
- 60 days
- Class
- Class II
- Product code
- HQD
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K943177 (1994). 18 ancestors in all, the oldest P860022 (1987). 19 later devices descend from it, 5 citing it directly.
- 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 backK071266 Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · Recalled
- 1 generation backK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
- This deviceK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016
- Descendant · cites it directly · 14 of its ownK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
- Descendant · 2 generations on · 9 of its ownK180616 OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens…Contamac, Ltd. · 2018
- Descendant · cites it directly · 7 of its ownK212631 Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd. · 2022
- Descendant · cites it directly · 6 of its ownK203571 Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021
- Descendant · 2 generations on · 5 of its ownK223394 Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E…Visionary Optics, LLC · 2022
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017 · cites it directly14descendants
- K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A)…Contamac, Ltd. · 2018 · 2 generations on9descendants
- K212631Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd. · 2022 · cites it directly7descendants
- K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021 · cites it directly6descendants
- K223394Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A…Visionary Optics, LLC · 2022 · 2 generations on5descendants
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 | K071266 | Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens | Bausch & Lomb, Inc. | 2007 | 2 |
| −1 | K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | Boston Foundation For Sight | 2016 | — |
| 0 (this device) | K161461 | BostonSight PD Prosthetic Device | Bostonsight | 2016 | — |
| +1 | K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | Bausch + Lomb, Incorporated | 2017 | — |
| +2 | K180616 | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100… | Contamac, Ltd. | 2018 | — |
| +1 | K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | Contamac, Ltd. | 2022 | — |
| +1 | K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2021 | — |
| +2 | K223394 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon… | Visionary Optics, LLC | 2022 | — |
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 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 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 |
|---|---|---|---|
| * | K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral LensSummary page 6…• “BostonSight IC Corneal & Scleral Lens” – Primary Predicate Manufactured by Boston Foundation for Sight 510(k) number; K153066 • “BostonR Scleral (itafluorofocon B) RGP Contact Lens for Daily Wear” – Reference Predicate… | 2016 |
| * | P860022 | Boston Equalens (Itaflurofocon a)/Equalens II (Oprifocon a) Rigid Gas Permeable Contact…Summary page 6…(itafluorofocon B) RGP Contact Lens for Daily Wear” – Reference Predicate Manufactured by Boston Foundation for Sight PMA number; P860022/S40 Device Description: The BostonSight PD Prosthetic Device is a daily wear, prosthetic device for the ocular surface lathe cu… | 1987 |
| † | K033594 | Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses | 2004 |
| † | K022128 | Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact Lens | 2002 |
| † | K071266 | Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens | 2007 |
What descends from it? (19)
See all 195 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | 2017 | 14 |
| K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | 2022 | 7 |
| K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | 2021 | 6 |
| K183175 | BostonSight Scleral | 2019 | 1 |
| K170335 | Custom Stable (TM) Rigid Gas Permeable Scleral Contact Lens | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2025 | Class II | Z-2191-2025 | Process control | Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 18 ancestors have a recall of any class.
- Of its descendants, K171404 (Bausch + Lomb, Incorporated, 2017) has gone furthest, with 14 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. 2016, 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 Boston Sight PD Prosthetic Device for daily wear is indicated for therapeutic use for the management of a distorted corneal surface that: 1. precludes satisfactory spectacle lens correction 2. demonstrates significant improved rigid contact lens corrected vision 3. is incapable of wearing traditional corneal lenses because of the inability to achieve adequate lens centration/stability and/or tolerance to physical contact with a lens Causes of corneal…
Read the full statement (223 words)
The Boston Sight PD Prosthetic Device for daily wear is indicated for therapeutic use for the management of a distorted corneal surface that:
1. precludes satisfactory spectacle lens correction
2. demonstrates significant improved rigid contact lens corrected vision
3. is incapable of wearing traditional corneal lenses because of the inability to achieve adequate lens centration/stability and/or tolerance to physical contact with a lens
Causes of corneal distortion include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid marginal degeneration, Salzmann’s nodular degeneration), corneal dystrophy (e.g, lattice dystrophy, Reis-Bucklers dystrophy), and scarring from surgery (e.g. corneal transplant, LASIK, radial keratotomy), infection, or trauma.
The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes with ocular surface disease from dry eye (e.g. ocular Graft-versus-Host disease, Sjogren’s syndrome, dry eye syndrome), limbal stem cell deficiency (e.g.Stevens-Johnson syndrome, chemical and thermal burns, radiation), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the BostonSight PD Prosthetic Device may incidentally provide correction of refractive error.
The BostonSight PD Prosthetic Device may be cleaned and disinfected using a chemical (not heat) care system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K161461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161461: BostonSight PD Prosthetic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161461
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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