510(k) · Cleared
ClearedOptimum GP (Roflufocon a,B,C,D&E) Daily Wear Contact Lens.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contamac, Ltd. · HQD Lens, Contact (Other Material) - Daily
Cleared on May 1, 2007 as substantially equivalent to K053124 (Bausch & Lomb, Incorporated, 2006) and 1 other predicate after a 55-day review. Its family tree reaches back 4 generations to 1994. 10 later devices descend from it.
- Decided
- May 1, 2007
- Review
- 55 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K943177 (1994). 5 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- 3 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- 2 generations backK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
- 1 generation backK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
- This deviceK070628 Optimum GP (Roflufocon a,B,C,D&E) Daily Wear Contact Lens.Contamac, Ltd. · 2007
- Descendant · cites it directly · 8 of its ownK161100 Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear…Contamac, Ltd. · 2016
- Descendant · 2 generations on · 4 of its ownK213538 Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas…Acuity Polymers, Inc. · 2021
- Descendant · 3 generations on · 3 of its ownK240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens…Acuity Polymers, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK171575 ENFLU 18 (enflufocon A) Daily Wear Contact LensContamac, Ltd. · 2017
- Descendant · 4 generations on · 0 of its ownK242393 Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with…Acuity Polymers, Inc. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd. · 2016 · cites it directly8descendants
- K213538Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2021 · 2 generations on4descendants
- K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon…Acuity Polymers, Inc. · 2024 · 3 generations on3descendants
- K171575ENFLU 18 (enflufocon A) Daily Wear Contact LensContamac, Ltd. · 2017 · 2 generations on1descendant
- K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG®…Acuity Polymers, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | 1 |
| −3 | K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| −2 | K020006 | Dyna Intra-Limbal Lens | Lens Dynamics, Inc. | 2002 | — |
| −1 | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)… | Bausch & Lomb, Incorporated | 2006 | — |
| 0 (this device) | K070628 | Optimum GP (Roflufocon a,B,C,D&E) Daily Wear Contact Lens. | Contamac, Ltd. | 2007 | — |
| +1 | K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | Contamac, Ltd. | 2016 | — |
| +2 | K213538 | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable… | Acuity Polymers, Inc. | 2021 | — |
| +3 | K240618 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™… | Acuity Polymers, Inc. | 2024 | — |
| +2 | K171575 | ENFLU 18 (enflufocon A) Daily Wear Contact Lens | Contamac, Ltd. | 2017 | — |
| +4 | K242393 | Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™… | Acuity Polymers, Inc. | 2024 | — |
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 |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas…Summary page 2…and the Boston XO® (hexafocon A) Rigid Gas 1400 North Goodman Street Permeable Contact Lenses 510(k) #K053124 Rochester, NY 14603 2.) Lens Dynamics Dyna Intra-Limbal Lens 5 10(k) #K020006 14998… | 2006 |
| * | K020006 | Dyna Intra-Limbal LensSummary page 2…Street Permeable Contact Lenses 510(k) #K053124 Rochester, NY 14603 2.) Lens Dynamics Dyna Intra-Limbal Lens 5 10(k) #K020006 14998 W. 6 th Avenue, Suite 830 Golden, CO 80401 Device Description: The OPTIMUM GP (roflufocon A, B, C, D & E)… | 2002 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K161100 (Contamac, Ltd., 2016) has gone furthest, with 8 descendants of its own.
- 7 other devices also cite its predicate K053124.
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. 2007, 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 OPTIMUM GP (roflufocon A, B, C, D & E) Daily Wear Contact Lens 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 as stated in the FDA summary.
https://510kreport.com/device/K070628 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070628: Optimum GP (Roflufocon a,B,C,D&E) Daily Wear Contact Lens..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070628
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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