510(k) · Cleared
ClearedOPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Contamac, Ltd. · MUW Lens, Contact (Orthokeratology)
Cleared on Jul 13, 2016 as substantially equivalent to K033594 (Contamac, Ltd., 2004) and 2 other predicates after a 106-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jul 13, 2016
- Review
- 106 days
- Class
- Class II
- Product code
- MUW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K943177 (1994). 16 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 backK071266 Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · Recalled
- This deviceK160859 OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)Contamac, Ltd. · 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 | K071266 | Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens | Bausch & Lomb, Inc. | 2007 | 2 |
| 0 (this device) | K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | Contamac, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 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 MUW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 GP (Oxygen Permeable) Daily Wear K033594 Contact Lenses (roflufocon A, B, C, D, & E) Contex, Inc. CONTEX OK (orthokeratology) con… | 2004 |
| * | K973697 | Airperm (Siflufocon a) Rigid Gas Permeable OK Contact Lenses for Daily Wear…Summary page 5…K033594 Contact Lenses (roflufocon A, B, C, D, & E) Contex, Inc. CONTEX OK (orthokeratology) contact lens K973697 Polymer Technology Boston X02 (hexafocon B) Daily Wear Contact K071266 Lens Dev… | 1998 |
| * | K071266 | Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensSummary page 5…Inc. CONTEX OK (orthokeratology) contact lens K973697 Polymer Technology Boston X02 (hexafocon B) Daily Wear Contact K071266 Lens Device Description: The OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) may be prescri… | 2007 |
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.
- 3 of the 16 ancestors have a recall of any class.
- 4 other devices also cite its predicate K033594.
How does its category compare?
All MUW devicesMUW Lens, Contact (Orthokeratology): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MUW
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · MUW
Too few MUW 510(k)s in any year since 2007 to give a median.
Recalls per year · MUW
No recall names MUW since 2007.
Adverse event reports per year · MUW
1in 2023
MAUDE reports naming product code MUW, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OPTIMUM GP OK contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.
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/K160859 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160859: OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160859
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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