510(k) · Cleared
ClearedBostonSight IC Corneal Lens, BostonSight IC Scleral Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Foundation For Sight · HQD Lens, Contact (Other Material) - Daily
Cleared on Feb 9, 2016 as substantially equivalent to K033594 (Contamac, Ltd., 2004) and 2 other predicates after a 110-day review. Its family tree reaches back 5 generations to 1994. 20 later devices descend from it.
- Decided
- Feb 9, 2016
- Review
- 110 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K943177 (1994). 17 ancestors in all, the oldest P860022 (1987). 20 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- 4 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- 3 generations backK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
- 2 generations backK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
- 1 generation backK071266 Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · Recalled
- This deviceK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
- Descendant · cites it directly · 19 of its ownK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
- Descendant · 2 generations on · 14 of its ownK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
- Descendant · 3 generations on · 9 of its ownK180616 OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens…Contamac, Ltd. · 2018
- Descendant · 2 generations on · 7 of its ownK212631 Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd. · 2022
- Descendant · 2 generations on · 6 of its ownK203571 Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K161461BostonSight PD Prosthetic DeviceBostonsight · 2016 · cites it directly19descendants
- K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017 · 2 generations on14descendants
- K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A)…Contamac, Ltd. · 2018 · 3 generations on9descendants
- K212631Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd. · 2022 · 2 generations on7descendants
- K203571Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | 1 |
| −4 | K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| −3 | K020006 | Dyna Intra-Limbal Lens | Lens Dynamics, Inc. | 2002 | — |
| −2 | 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 |
| 0 (this device) | K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | Boston Foundation For Sight | 2016 | — |
| +1 | K161461 | BostonSight PD Prosthetic Device | Bostonsight | 2016 | 1 |
| +2 | K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | Bausch + Lomb, Incorporated | 2017 | — |
| +3 | K180616 | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100… | Contamac, Ltd. | 2018 | — |
| +2 | K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | Contamac, Ltd. | 2022 | — |
| +2 | K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2021 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K033594 | Optimum GP (Oxygen Permeable) Daily Wear Contact LensesSummary page 5…Device name 510(k) number manufacturer Contamac Ltd. OPTIMUM EXTRA (Oxygen Permeable) Daily Wear K033594 Contact Lenses (roflufocon D) OPTIMUM EXTREME (Oxygen Permeable) Daily… | 2004 |
| * | K022128 | Boston Equalens II (Oprifocon a) Rigid Gas Permeable Contact LensSummary page 5…xygen Permeable) Daily Wear Contact Lenses (roflufocon E) Bausch & Lomb, Inc. Boston EQUALENS II (oprifocon A) K022128 Rigid Gas Permeable Contact Lenses Bausch & Lomb, Inc. Boston XO2 (hexafocon B) Daily Wear Cont… | 2002 |
| * | K071266 | Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensSummary page 5…K022128 Rigid Gas Permeable Contact Lenses Bausch & Lomb, Inc. Boston XO2 (hexafocon B) Daily Wear Contact K071266 Lens Device Description: The BostonSight Irregular Cornea (IC) Corneal & Scleral Lenses are lathe c… | 2007 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161461 | BostonSight PD Prosthetic Device | 2016 | 19 |
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 22 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K161461 (Bostonsight, 2016) has gone furthest, with 19 descendants of its own.
- 4 other devices also cite its predicate K033594.
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 BostonSight IC Corneal & Scleral Lenses for Daily Wear are indicated for the correction of refractive error in aphakic and not aphakic persons. The lenses may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery. Eyecare practitioners may…
Read the full statement (99 words)
The BostonSight IC Corneal & Scleral Lenses for Daily Wear are indicated for the correction of refractive error in aphakic and not aphakic persons. The lenses may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens 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/K153066 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153066: BostonSight IC Corneal Lens, BostonSight IC Scleral Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153066
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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