510(k) · Cleared
Recalled · Class III · 2018Optimum 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 Mar 19, 2004 as substantially equivalent to K970698 (Polymer Technology Corp., 1997) and 4 other predicates after a 127-day review. Its family tree reaches back 2 generations to 1994. 28 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 19, 2004
- Review
- 127 days
- Class
- Class II
- Product code
- HQD
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 2 generations to K942365 (1994). 8 ancestors in all, the oldest K940277 (1994). 28 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK942365 Boston ViiPolymer Technology Corp. · 1994
- 1 generation backK970698 Boston ES Multivision (Enflufocon a) Contact LensPolymer Technology Corp. · 1997
- This deviceK033594 Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 2004
- Descendant · cites it directly · 20 of its ownK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
- Descendant · 2 generations on · 19 of its ownK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
- Descendant · 3 generations on · 14 of its ownK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
- Descendant · 4 generations on · 9 of its ownK180616 OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens…Contamac, Ltd. · 2018
- Descendant · cites it directly · 8 of its ownK161100 Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear…Contamac, Ltd. · 2016
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016 · cites it directly20descendants
- K161461BostonSight PD Prosthetic DeviceBostonsight · 2016 · 2 generations on19descendants
- K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017 · 3 generations on14descendants
- K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A)…Contamac, Ltd. · 2018 · 4 generations on9descendants
- K161100Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact LensesContamac, Ltd. · 2016 · cites it directly8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942365 | Boston Vii | Polymer Technology Corp. | 1994 | — |
| −1 | K970698 | Boston ES Multivision (Enflufocon a) Contact Lens | Polymer Technology Corp. | 1997 | — |
| 0 (this device) | K033594 | Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses | Contamac, Ltd. | 2004 | — |
| +1 | K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | Boston Foundation For Sight | 2016 | — |
| +2 | K161461 | BostonSight PD Prosthetic Device | Bostonsight | 2016 | 1 |
| +3 | K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | Bausch + Lomb, Incorporated | 2017 | — |
| +4 | K180616 | OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100… | Contamac, Ltd. | 2018 | — |
| +1 | K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | Contamac, Ltd. | 2016 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 3 | 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970698 | Boston ES Multivision (Enflufocon a) Contact LensSummary page 2…Device name: 1.) Polymer Technology Boston ES Multifocal, Daily Wear 1400 North Goodman Street 510(k) #: K970698 Rochester, NY 14603 2.) Polymer Technology Boston XO, Daily Wear 1400 North Goodman Stre… | 1997 |
| * | K000795 | Rigid Gas Permeable Contact LensSummary page 2…: K970698 Rochester, NY 14603 2.) Polymer Technology Boston XO, Daily Wear 1400 North Goodman Street 510(k) #: K000795 Rochester, NY 14603 BOSTON XO, EO, ES, 7 RXD, Daily Wear… | 2000 |
| * | K002025 | Rigid Gas Permeable Contact LensSummary page 2…ochester, NY 14603 BOSTON XO, EO, ES, 7 RXD, Daily Wear 510(k) #: K002025 (wet shipped lenses) 3.) Paragon Vision Sciences FluoroPerm 30, 510(k) #: K940277 947 E. Impala Ave… | 2000 |
| * | K940277 | Paflufocon a, B, C & DSummary page 2…r 510(k) #: K002025 (wet shipped lenses) 3.) Paragon Vision Sciences FluoroPerm 30, 510(k) #: K940277 947 E. Impala Avenue FluoroPerm 60, 510(k) #: K940277 Mewa, AZ 85204… | 1994 |
| Kept off the family tree | P870024 | FDA’s P870024 is Fluoroperm RGP Contact Lenses Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1987 |
| * | K990264 | Comfortkone, Keratoconus Aspheric, Rigid Gas Permeable (RGP), Daily Wear Contact LensSummary page 2…FluoroPerm HIDS, P87024-S36 4.) Metro Optics, Inc. ComfortKone, Daily Wear 15802 Vision Drive 510(k) # K990264 (Keratoconus Contact Lens Design) Pflugerville, TX 78660 Device Description:… | 1999 |
What descends from it? (28)
See all 285 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | 2016 | 20 |
| K161100 | Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses | 2016 | 8 |
| K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | 2016 | 0 |
| K152724 | Eyeprintpro (Roflufocon D) Scleral GP Lenses | 2016 | 0 |
| K062548 | Modification to Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 3, 2018 | Class III | Z-2982-2018 | Process control | Vials labeled for the prescriptions contained incorrect lenses |
| Jul 3, 2018 | Class III | Z-2981-2018 | Process control | Vials labeled for the prescriptions contained incorrect lenses |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K153066 (Boston Foundation For Sight, 2016) has gone furthest, with 20 descendants of its own.
- 1 other device also cites its predicate K970698.
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) Spherical 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…
Read the full statement (411 words)
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Spherical 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.
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Torie 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 and/or possesses refractive astigmatism not exceeding 10.00 diopters. 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.
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Multifocal/Bifocal 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 and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. 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.
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Keratoconus Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons. 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/K033594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033594: 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 6, 2026. https://510kreport.com/device/K033594
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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