510(k) · Cleared
ClearedMieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV Blocker
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearlab Pte, Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Apr 2, 2003 as substantially equivalent to K020855 (Igel Vision Care Pte, Ltd., 2002) and 2 other predicates after a 76-day review. Its family tree reaches back 2 generations to 1996. 6 later devices descend from it.
- Decided
- Apr 2, 2003
- Review
- 76 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K962804 (1996). 4 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 1 generation backK980634 Frequency UV (Etafilcon a) Hydrophilic Contact Lens for Daily Wear…Aspect Vision Care, Ltd. · 1998
- This deviceK030167 Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility…Clearlab Pte, Ltd. · 2003
- Descendant · cites it directly · 5 of its ownK052290 Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006
- Descendant · 2 generations on · 3 of its ownK080632 CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd. · 2008
- Descendant · 3 generations on · 1 of its ownK102895 One Day Flat PackMenicon Co, Ltd. · 2011
- Descendant · 3 generations on · 0 of its ownK192129 ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic)…Clearlab SG Pte, Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK180819 One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensMenicon Co, Ltd. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K052290Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006 · cites it directly5descendants
- K080632CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd. · 2008 · 2 generations on3descendants
- K102895One Day Flat PackMenicon Co, Ltd. · 2011 · 3 generations on1descendant
- K192129ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan…Clearlab SG Pte, Ltd. · 2019 · 3 generations on0descendants
- K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensMenicon Co, Ltd. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −1 | K980634 | Frequency UV (Etafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and… | Aspect Vision Care, Ltd. | 1998 | — |
| 0 (this device) | K030167 | Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV… | Clearlab Pte, Ltd. | 2003 | — |
| +1 | K052290 | Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact Lens | Clearlab Pte, Ltd. | 2006 | — |
| +2 | K080632 | CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact Lens | Clearlab SG Pte, Ltd. | 2008 | — |
| +3 | K102895 | One Day Flat Pack | Menicon Co, Ltd. | 2011 | — |
| +3 | K192129 | ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact… | Clearlab SG Pte, Ltd. | 2019 | — |
| +3 | K180819 | One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens | Menicon Co, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K020855 | Igel 55UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,Igel 55 UV…Summary page 2…lent Predicate Devices: The MIERU (etafilcon A) Soft Contact Lenses are substantially equivalent to the following predicate devices: 1. IGEL 55UV (niethafilcon A), K020855, Manufactured by IGEL Visioncare Pte. Ltd. 2. Frequency 58 (etafilcon A), K980634, manufactured by Aspect Vision Care. 3.… | 2002 |
| * | K980634 | Frequency UV (Etafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)Summary page 2…equivalent to the following predicate devices: 1. IGEL 55UV (niethafilcon A), K020855, Manufactured by IGEL Visioncare Pte. Ltd. 2. Frequency 58 (etafilcon A), K980634, manufactured by Aspect Vision Care. 3. AcuVue 2 (etafilcon A), K962804, manufactured by Vistakon. Device Description: The… | 1998 |
| * | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV BlockerSummary page 2…con A), K020855, Manufactured by IGEL Visioncare Pte. Ltd. 2. Frequency 58 (etafilcon A), K980634, manufactured by Aspect Vision Care. 3. AcuVue 2 (etafilcon A), K962804, manufactured by Vistakon. Device Description: The MIERU (etafilcon A) Soft (hydrophilic) Contact Lens is available as a single… | 1996 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052290 | Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact Lens | 2006 | 5 |
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 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K052290 (Clearlab Pte, Ltd., 2006) has gone furthest, with 5 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 MIERU (etafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The MIERU (etafilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of…
Read the full statement (207 words)
The MIERU (etafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The MIERU (etafilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may have astigmatism of 7.00D or less.
The MIERU (etafilcon A) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +4.00D to -5.00D and have near add requirements up to 3.00D.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030167 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030167: Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV Blocker.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030167
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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