510(k) · Cleared
ClearedOcular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily Wear Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ocular Sciences Puerto Rico, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Nov 24, 1999 as substantially equivalent to K984046 (Ocular Sciences Puerto Rico, Inc., 1999) and 3 other predicates after a 141-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Nov 24, 1999
- Review
- 141 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K942214 (1994). 4 ancestors in all, the oldest P890023 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK942214 H55 Hydrophilic Contact LensMartin S. Knopf Assoc., Inc. · 1994
- 2 generations backK972303 Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc. · 1997
- 1 generation backK984046 Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc. · 1999
- This deviceK992264 Ocular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily…Ocular Sciences Puerto Rico, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK031477 Hydrogenics 2.0 60 UV Asphere (Ocufilcon F) Soft (Hydrophilic)…Ocular Sciences, Inc. · 2003
Most influential descendants
Showing 1 of 1 · See all- K031477Hydrogenics 2.0 60 UV Asphere (Ocufilcon F) Soft (Hydrophilic) Contact LensOcular Sciences, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942214 | H55 Hydrophilic Contact Lens | Martin S. Knopf Assoc., Inc. | 1994 | — |
| −2 | K972303 | Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact Lens | Ocular Sciences Puerto Rico, Inc. | 1997 | — |
| −1 | K984046 | Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens | Ocular Sciences Puerto Rico, Inc. | 1999 | — |
| 0 (this device) | K992264 | Ocular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily Wear Soft… | Ocular Sciences Puerto Rico, Inc. | 1999 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (4)
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 |
|---|---|---|---|
| * | K984046 | Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensSummary page 1…on “F") UV Blocking Daily Wear Contact Lens with In-Monomer Tint is equivalent to the daily wear lens of the same material but of a modified water content, as cleared in K984046, K942214 and K972303 for daily wear, and P890023/526, P890023/54 P890023/S7 for extended wear,currently marketed by Ocular Scienc… | 1999 |
| * | K942214 | H55 Hydrophilic Contact LensSummary page 1…V Blocking Daily Wear Contact Lens with In-Monomer Tint is equivalent to the daily wear lens of the same material but of a modified water content, as cleared in K984046, K942214 and K972303 for daily wear, and P890023/526, P890023/54 P890023/S7 for extended wear,currently marketed by Ocular Sciences, Inc.… | 1994 |
| * | K972303 | Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensSummary page 1…aily Wear Contact Lens with In-Monomer Tint is equivalent to the daily wear lens of the same material but of a modified water content, as cleared in K984046, K942214 and K972303 for daily wear, and P890023/526, P890023/54 P890023/S7 for extended wear,currently marketed by Ocular Sciences, Inc. The BIOMEDI… | 1997 |
| * | P890023 | H55 Hydrophilic Contact LensSummary page 1…In-Monomer Tint is equivalent to the daily wear lens of the same material but of a modified water content, as cleared in K984046, K942214 and K972303 for daily wear, and P890023/526, P890023/54 P890023/S7 for extended wear,currently marketed by Ocular Sciences, Inc. The BIOMEDICS® 60 (ocufilcon "F") UV Bl… | 1989 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031477 | Hydrogenics 2.0 60 UV Asphere (Ocufilcon F) Soft (Hydrophilic) Contact Lens | 2003 | 0 |
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 5 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K031477 (Ocular Sciences, Inc., 2003) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K984046.
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?
Spherical: Biomedics® 60 (ocufilcon F) UV Blocking Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. Toric: Biomedics® 60 (ocufilcon F) UV Blocking Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes…
Read the full statement (166 words)
Spherical:
Biomedics® 60 (ocufilcon F) UV Blocking Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.
Toric:
Biomedics® 60 (ocufilcon F) UV Blocking Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 10.00 diopters.
The lenses may be prescribed for Daily Wear in not-aphakic persons. The eye care practitioner may prescribe the contact lens for either single use disposable wear or for frequent replacement wear, with cleaning, disinfection, and scheduled replacement (SEE WEARING SCHEDULE). When prescribing for frequent replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system.
Biomedics® 60 (ocufilcon F) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
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/K992264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992264: Ocular Sciences, Inc., Biomedics 60 (Ocufilcon F) UV Blocking Daily Wear Soft 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/K992264
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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