510(k) · Cleared
ClearedModification to Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses
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 Nov 1, 2006 as substantially equivalent to K033594 (Contamac, Ltd., 2004) after a 63-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Nov 1, 2006
- Review
- 63 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942365 (1994). 9 ancestors in all, the oldest K940277 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK942365 Boston ViiPolymer Technology Corp. · 1994
- 2 generations backK970698 Boston ES Multivision (Enflufocon a) Contact LensPolymer Technology Corp. · 1997
- 1 generation backK033594 Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 2004 · Recalled
- This deviceK062548 Modification to Optimum GP (Oxygen Permeable) Daily Wear Contact…Contamac, Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942365 | Boston Vii | Polymer Technology Corp. | 1994 | — |
| −2 | K970698 | Boston ES Multivision (Enflufocon a) Contact Lens | Polymer Technology Corp. | 1997 | — |
| −1 | K033594 | Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses | Contamac, Ltd. | 2004 | 2 |
| 0 (this device) | K062548 | Modification to Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses | Contamac, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 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? (1)
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 3…The OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lzma is substantially equivalent to Contamac Ltd. own unmodified predicate devices: 1. Optimum GP (roflufocon) K033594, Contamac Ltd. INDICATIONS FOR USE: The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E)… | 2004 |
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 12 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 9 ancestors have a recall of any class.
- 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.
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, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia.
The lens may be disinfected with a chemical disinfection system only.
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/K062548 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062548: Modification to Optimum GP (Oxygen Permeable) Daily Wear 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/K062548
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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