510(k) · Cleared
ClearedAquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact Lens
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 May 15, 2006 as substantially equivalent to K992692 (Benz Research and Development Corp., 1999) and 2 other predicates after a 265-day review. Its family tree reaches back 3 generations to 1996. 5 later devices descend from it.
- Decided
- May 15, 2006
- Review
- 265 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K962804 (1996). 7 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 2 generations backK980634 Frequency UV (Etafilcon a) Hydrophilic Contact Lens for Daily Wear…Aspect Vision Care, Ltd. · 1998
- 1 generation backK030167 Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility…Clearlab Pte, Ltd. · 2003
- This deviceK052290 Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006
- Descendant · cites it directly · 3 of its ownK080632 CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd. · 2008
- Descendant · 2 generations on · 1 of its ownK102895 One Day Flat PackMenicon Co, Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK192129 ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic)…Clearlab SG Pte, Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK180819 One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensMenicon Co, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK170286 Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens…Largan Medical Co., Ltd. · 2017
Most influential descendants
Showing 5 of 5 · See all- K080632CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact LensClearlab SG Pte, Ltd. · 2008 · cites it directly3descendants
- K102895One Day Flat PackMenicon Co, Ltd. · 2011 · 2 generations on1descendant
- K192129ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan…Clearlab SG Pte, Ltd. · 2019 · 2 generations on0descendants
- K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact LensMenicon Co, Ltd. · 2018 · 2 generations on0descendants
- K170286Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon…Largan Medical Co., Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −2 | K980634 | Frequency UV (Etafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and… | Aspect Vision Care, Ltd. | 1998 | — |
| −1 | K030167 | Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV… | Clearlab Pte, Ltd. | 2003 | — |
| 0 (this device) | K052290 | Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact Lens | Clearlab Pte, Ltd. | 2006 | — |
| +1 | K080632 | CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact Lens | Clearlab SG Pte, Ltd. | 2008 | — |
| +2 | K102895 | One Day Flat Pack | Menicon Co, Ltd. | 2011 | — |
| +2 | K192129 | ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact… | Clearlab SG Pte, Ltd. | 2019 | — |
| +2 | K180819 | One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens | Menicon Co, Ltd. | 2018 | — |
| +1 | K170286 | Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan… | Largan Medical Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K992692 | Extreme H20 (Hioxifilicon a) Soft Contact LensSummary page 2…e AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Soft Contact Lenses are substantially equivalent to the following predicate devices: 1. Extreme H 20 (hioxifilcon A), K992692, Manufactured by Hydrogel Vision Corp. 2. Benz-G 5X (hioxifilcon A), K983773, Manufactured by Benz Research & Development… | 1999 |
| * | K983773 | Benz G-5X (Hioxifilcon a) Soft Daily Wear Contact LensSummary page 2…lly equivalent to the following predicate devices: 1. Extreme H 20 (hioxifilcon A), K992692, Manufactured by Hydrogel Vision Corp. 2. Benz-G 5X (hioxifilcon A), K983773, Manufactured by Benz Research & Development 3. MIERU (etafilcon A), K030167, manufactured by ClearLab International PTE LTD.… | 1998 |
| * | K030167 | Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV BlockerSummary page 2…con A), K992692, Manufactured by Hydrogel Vision Corp. 2. Benz-G 5X (hioxifilcon A), K983773, Manufactured by Benz Research & Development 3. MIERU (etafilcon A), K030167, manufactured by ClearLab International PTE LTD. Device Description: The AQUASOFT ALL-DAY & ALL-DAY T (hioxifilcon A) Soft (hyd… | 2003 |
What descends from it? (5)
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 10 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K080632 (Clearlab SG Pte, Ltd., 2008) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K992692.
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 AQUASOFT ALL-DAY (hioxifilcon 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 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be cleaned and disinfected using a chemical (not heat) lens care system. The…
Read the full statement (169 words)
The AQUASOFT ALL-DAY (hioxifilcon 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 0.75 diopters or less where the astigmatism does not interfere with visual acuity.
The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The AQUASOFT ALL-DAY T (hioxifilcon 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.OOD of astigmatism or less.
The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
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/K052290 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052290: Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear 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/K052290
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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