510(k) · Cleared
ClearedBiomedics UV Colors (Ocufilcon D) 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 Dec 20, 2001 as substantially equivalent to K984046 (Ocular Sciences Puerto Rico, Inc., 1999) and 1 other predicate after a 69-day review. Its family tree reaches back 3 generations to 1994. 4 later devices descend from it.
- Decided
- Dec 20, 2001
- Review
- 69 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K942214 (1994). 5 ancestors in all, the oldest P890023 (1989). 4 later devices descend from it, 2 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 deviceK013377 Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact LensOcular Sciences Puerto Rico, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK182523 Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic)…Largan Medical Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK242916 Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact…Largan Medical Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK202129 Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic)…Largan Medical Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK152657 SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact LensSmart Performer Corp., Ltd. · 2016
Most influential descendants
Showing 4 of 4 · See all- K182523Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd. · 2018 · cites it directly2descendants
- K242916Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact LensLargan Medical Co., Ltd. · 2025 · 2 generations on0descendants
- K202129Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB…Largan Medical Co., Ltd. · 2021 · 2 generations on0descendants
- K152657SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact LensSmart Performer Corp., Ltd. · 2016 · 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) | K013377 | Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens | Ocular Sciences Puerto Rico, Inc. | 2001 | — |
| +1 | K182523 | Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. | 2018 | — |
| +2 | K242916 | Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Largan Medical Co., Ltd. | 2025 | — |
| +2 | K202129 | Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens… | Largan Medical Co., Ltd. | 2021 | — |
| +1 | K152657 | SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens | Smart Performer Corp., Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K984046 | Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensSummary page 1…. This lens material, packaging, manufacturing and sterilization process is equivalent to BIOMEDICS®UV (ocufilcon D) described in submission PMA890023/54 and S7, 510(K) K984046. Ocular Sciences 510(K) PREMARKET NOTIFICATION Reference OCDCS5 (ocufilcon D) soft (hydrophilic) Section :3 cont… | 1999 |
| * | K954603 | Durasoft Freshlook UV Colors; Durasoft 3 Freshlook UV Lite TintSummary page 2…6. Opagque colored lens: FRESHLOOK Colorblends (phemfilcon A) Sphere (Hydrophilic) Contact lenses marketed internationally by Wesley Jessen under PMA 830037 S33/S39 and K954603. Ocular Sciences (ocufilcon D) soft (hydrophilic) contact lens 510(K) PREMARKET NOTIFICATION Reference OCDC55… | 1996 |
What descends from it? (4)
2 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 7 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K182523 (Largan Medical Co., Ltd., 2018) has gone furthest, with 2 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?
BIOMEDICS® UV Colors spherical lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact Lens are indicated for daily wear to enhance or alter the apparent color of the eye. The eye…
Read the full statement (132 words)
BIOMEDICS® UV Colors spherical lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
The BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact Lens are indicated for daily wear to enhance or alter the apparent color of the eye. The eye care practitioner may prescribe the contact lens for either single use disposable wear and for frequent replacement wear. When prescribed for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.
The Biomedics® UV Colors 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/K013377 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013377: Biomedics UV Colors (Ocufilcon D) 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/K013377
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026