510(k) · Cleared
ClearedBiomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) 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 Jan 29, 1999 as substantially equivalent to K942214 (Martin S. Knopf Assoc., Inc., 1994) and 2 other predicates after a 161-day review. Its family tree reaches back 2 generations to 1994. 13 later devices descend from it.
- Decided
- Jan 29, 1999
- Review
- 161 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K942214 (1994). 3 ancestors in all, the oldest P890023 (1989). 13 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK942214 H55 Hydrophilic Contact LensMartin S. Knopf Assoc., Inc. · 1994
- 1 generation backK972303 Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc. · 1997
- This deviceK982947 Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc. · 1999
- Descendant · cites it directly · 11 of its ownK020193 Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft…Cl Mcintosh · 2002
- Descendant · 2 generations on · 9 of its ownK091339 Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 3 of its ownK181232 Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact…Largan Medical Co., Ltd. · 2018
- Descendant · 4 generations on · 2 of its ownK182523 Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic)…Largan Medical Co., Ltd. · 2018
- Descendant · 3 generations on · 2 of its ownK182247 ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses…Vizionfocus, Inc. · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K020193Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact LensCl Mcintosh · 2002 · cites it directly11descendants
- K091339Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2010 · 2 generations on9descendants
- K181232Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV…Largan Medical Co., Ltd. · 2018 · 3 generations on3descendants
- K182523Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd. · 2018 · 4 generations on2descendants
- K182247ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)Vizionfocus, Inc. · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942214 | H55 Hydrophilic Contact Lens | Martin S. Knopf Assoc., Inc. | 1994 | — |
| −1 | K972303 | Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact Lens | Ocular Sciences Puerto Rico, Inc. | 1997 | — |
| 0 (this device) | K982947 | Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact Lens | Ocular Sciences Puerto Rico, Inc. | 1999 | — |
| +1 | K020193 | Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic)… | Cl Mcintosh | 2002 | — |
| +2 | K091339 | Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens | CooperVision, Inc. | 2010 | 1 |
| +3 | K181232 | Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan… | Largan Medical Co., Ltd. | 2018 | — |
| +4 | K182523 | Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. | 2018 | — |
| +3 | K182247 | ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted… | Vizionfocus, Inc. | 2018 | — |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K942214 | H55 Hydrophilic Contact LensSummary page 1…TANTIALLY EQUIVALENT TO: The BIOMEDICSR 55 (ocufilcon D) UV Blocking Contact lens for Daily Wear is equivalent to the daily wear lens of the same material as cleared in K942214, P890023/S26, and K972303 in-monomer visibility tint cast molded ocufilcon D for daily wear currently marketed by Ocular Science… | 1994 |
| * | P890023 | H55 Hydrophilic Contact LensSummary page 1…EQUIVALENT TO: The BIOMEDICSR 55 (ocufilcon D) UV Blocking Contact lens for Daily Wear is equivalent to the daily wear lens of the same material as cleared in K942214, P890023/S26, and K972303 in-monomer visibility tint cast molded ocufilcon D for daily wear currently marketed by Ocular Sciences, Inc. i… | 1989 |
| * | K972303 | Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensSummary page 1…The BIOMEDICSR 55 (ocufilcon D) UV Blocking Contact lens for Daily Wear is equivalent to the daily wear lens of the same material as cleared in K942214, P890023/S26, and K972303 in-monomer visibility tint cast molded ocufilcon D for daily wear currently marketed by Ocular Sciences, Inc. in the United Stat… | 1997 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 3.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K020193 (Cl Mcintosh, 2002) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K942214.
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?
The BIOMEDICS® 55 (ocufilcon D) UV Blocking soft (hydrophilic) contact lens is indicated for daily wear in not-aphakic, normal eyes which manifest myopia, hyperopia, or astigmatism in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Spherical lenses may mask astigmatism in patients with up to 2.00 diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or…
Read the full statement (117 words)
The BIOMEDICS® 55 (ocufilcon D) UV Blocking soft (hydrophilic) contact lens is indicated for daily wear in not-aphakic, normal eyes which manifest myopia, hyperopia, or astigmatism in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Spherical lenses may mask astigmatism in patients with up to 2.00 diopters that does not interfere with visual acuity. The lens may be dispensed in a daily disposable or scheduled replacement program. The lenses may be prescribed for daily wear for disposal after removal in the Disposable Lens Program or for cleaning and disinfection in the Scheduled Replacement Program, as recommended by the eyecare practitioner. The lens may be disinfected only with a chemical disinfection regimen.
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/K982947 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982947: Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982947
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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