510(k) · Cleared
ClearedHydrogenics 2.0 60 UV Asphere (Ocufilcon F) Soft (Hydrophilic) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ocular Sciences, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jul 18, 2003 as substantially equivalent to K992264 (Ocular Sciences Puerto Rico, Inc., 1999) and 1 other predicate after a 70-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Jul 18, 2003
- Review
- 70 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K942214 (1994). 8 ancestors in all, the oldest P890023 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK942214 H55 Hydrophilic Contact LensMartin S. Knopf Assoc., Inc. · 1994
- 3 generations backK972303 Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc. · 1997
- 2 generations backK984046 Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc. · 1999
- 1 generation backK992264 Ocular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily…Ocular Sciences Puerto Rico, Inc. · 1999
- This deviceK031477 Hydrogenics 2.0 60 UV Asphere (Ocufilcon F) Soft (Hydrophilic)…Ocular Sciences, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942214 | H55 Hydrophilic Contact Lens | Martin S. Knopf Assoc., Inc. | 1994 | — |
| −3 | K972303 | Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact Lens | Ocular Sciences Puerto Rico, Inc. | 1997 | — |
| −2 | K984046 | Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens | Ocular Sciences Puerto Rico, Inc. | 1999 | — |
| −1 | K992264 | Ocular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily Wear Soft… | Ocular Sciences Puerto Rico, Inc. | 1999 | — |
| 0 (this device) | K031477 | Hydrogenics 2.0 60 UV Asphere (Ocufilcon F) Soft (Hydrophilic) Contact Lens | Ocular Sciences, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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 LPL? 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 LPL device
- #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 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 |
|---|---|---|---|
| * | K992264 | Ocular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily Wear Soft Contact LensSummary page 1…lens material for the HYDROGENICSB 2.0 60 UV ASPHERE (ocufilcon F) is the same as the BiomedicsB 60 UV (ocufilcon F) lens in spherical design as described in submission K992264 cleared on November 24, 1999. The aspheric lens design for the HYDROGENICSB 2.0 60 UV ASPHERE (ocufilcon F) is the same design c… | 1999 |
| * | K020193 | Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact Lens | 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 9 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, 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 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
HYDROGENICSB 2.0 60 U V ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact lenses are indicated for the correction of visual acuity in persons with not-aphakic. non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism 2.00 diopters or less that does riot interfere with visual acuity. The HYDROGENICB 3.0 60 UV ASPHERE (ocufilcon F) Soft (H>drophilic) Contact Lenses are indicated for daily wear. The eye…
Read the full statement (133 words)
HYDROGENICSB 2.0 60 U V ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact lenses are indicated for the correction of visual acuity in persons with not-aphakic. non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism 2.00 diopters or less that does riot interfere with visual acuity.
The HYDROGENICB 3.0 60 UV ASPHERE (ocufilcon F) Soft (H>drophilic) Contact Lenses are indicated for daily wear. The eye care practitioner may prescribe the contact lenses for either single use disposable wear or for frequent replacement wear. When prescribed for frequent replacement planned replacement the lenses may be disinfected using a chemical or hydrogen peroxide disinfecting s>stcnis
The HYDROGENICSB 2.0 60 UV ASPHERE (ocufilcon F) Soft (H\,drophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031477: Hydrogenics 2.0 60 UV Asphere (Ocufilcon F) Soft (Hydrophilic) Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031477
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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