510(k) · Cleared
ClearedEyeprintpro (Roflufocon D) Scleral GP Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Vision Technologies · HQD Lens, Contact (Other Material) - Daily
Cleared on Apr 27, 2016 as substantially equivalent to K070628 (Contamac, Ltd., 2007) and 1 other predicate after a 218-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Apr 27, 2016
- Review
- 218 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K943177 (1994). 13 ancestors in all, the oldest K940277 (1994). No later device cites it as a predicate yet.
- 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 backK070628 Optimum GP (Roflufocon a,B,C,D&E) Daily Wear Contact Lens.Contamac, Ltd. · 2007
- This deviceK152724 Eyeprintpro (Roflufocon D) Scleral GP LensesAdvanced Vision Technologies · 2016
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 | K070628 | Optimum GP (Roflufocon a,B,C,D&E) Daily Wear Contact Lens. | Contamac, Ltd. | 2007 | — |
| 0 (this device) | K152724 | Eyeprintpro (Roflufocon D) Scleral GP Lenses | Advanced Vision Technologies | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K070628 | Optimum GP (Roflufocon a,B,C,D&E) Daily Wear Contact Lens.Summary page 5…re substantially equivalent to the following predicate devices: Predicate devices: “OPTIMUM GP” -Primary Predicate By Contamac ltd. 510(k) number; K070628 & K033594 Device Description: The EyePrintPRO (roflufocon D) Scleral GP Lens is a rigid gas permeable (RGP) lens designed from… | 2007 |
| * | K033594 | Optimum GP (Oxygen Permeable) Daily Wear Contact LensesSummary page 5…tially equivalent to the following predicate devices: Predicate devices: “OPTIMUM GP” -Primary Predicate By Contamac ltd. 510(k) number; K070628 & K033594 Device Description: The EyePrintPRO (roflufocon D) Scleral GP Lens is a rigid gas permeable (RGP) lens designed from measuremen… | 2004 |
| † | K083701 | Panasil Initial Contact and Panasil Tray | 2009 |
| † | K030987 | Contact Lens Storage Case | 2003 |
| † | K014162 | Modification to Optimum Cleaning, Disinfecting and | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 2 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K070628.
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 EyePrintPRO (roflufocon D) Scleral GP Lenses are indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with myopia or hyperopia. 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.…
Read the full statement (103 words)
The EyePrintPRO (roflufocon D) Scleral GP Lenses are indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with myopia or hyperopia. 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/K152724 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152724: Eyeprintpro (Roflufocon D) Scleral GP Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152724
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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