510(k) · Cleared
ClearedIgel 55UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,Igel 55 UV Multifocal (Methafilcon a) Soft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Igel Vision Care Pte, Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jun 4, 2002 as substantially equivalent to K003526 (Specialty Ultravision, Inc., 2001) after an 81-day review. Its family tree reaches back 1 generation to 2001. 7 later devices descend from it.
- Decided
- Jun 4, 2002
- Review
- 81 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003526 (2001). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003526 Specialty 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for…Specialty Ultravision, Inc. · 2001
- This deviceK020855 Igel 55UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily…Igel Vision Care Pte, Ltd. · 2002
- Descendant · cites it directly · 6 of its ownK030167 Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility…Clearlab Pte, Ltd. · 2003
- Descendant · 2 generations on · 5 of its ownK052290 Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006
- Descendant · 3 generations on · 3 of its ownK080632 CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd. · 2008
- Descendant · 4 generations on · 1 of its ownK102895 One Day Flat PackMenicon Co, Ltd. · 2011
- Descendant · 4 generations on · 0 of its ownK192129 ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic)…Clearlab SG Pte, Ltd. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K030167Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV BlockerClearlab Pte, Ltd. · 2003 · cites it directly6descendants
- K052290Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006 · 2 generations on5descendants
- K080632CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd. · 2008 · 3 generations on3descendants
- K102895One Day Flat PackMenicon Co, Ltd. · 2011 · 4 generations on1descendant
- K192129ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan…Clearlab SG Pte, Ltd. · 2019 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003526 | Specialty 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily… | Specialty Ultravision, Inc. | 2001 | — |
| 0 (this device) | K020855 | Igel 55UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,Igel… | Igel Vision Care Pte, Ltd. | 2002 | — |
| +1 | K030167 | Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV… | Clearlab Pte, Ltd. | 2003 | — |
| +2 | K052290 | Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact Lens | Clearlab Pte, Ltd. | 2006 | — |
| +3 | K080632 | CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact Lens | Clearlab SG Pte, Ltd. | 2008 | — |
| +4 | K102895 | One Day Flat Pack | Menicon Co, Ltd. | 2011 | — |
| +4 | K192129 | ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact… | Clearlab SG Pte, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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? (1)
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 |
|---|---|---|---|
| * | K003526 | Specialty 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear… | 2001 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030167 | Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV Blocker | 2003 | 6 |
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?
- Its one ancestor has no recall.
- Of its descendants, K030167 (Clearlab Pte, Ltd., 2003) has gone furthest, with 6 descendants of its own.
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 Igel 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The Igel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact lens for Daily Wear is indicated for the…
Read the full statement (208 words)
The Igel 55 UV (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
The Igel 55 UV Multifocal (methafilcon A) Soft (Hydrophilic) Contact lens for Daily Wear is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or not-aphakic persons with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity, in a power range of t4.00 to -5.00 Diopters and have near add requirements up to 3.00 Diopters.
The Igel55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 7.00 Diopters.
The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020855: Igel 55UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,Igel 55 UV Multifocal (Methafilcon a) Soft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020855
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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