510(k) · Cleared
ClearedAveo (omafilcon A) Soft (Hydrophilic) Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Supervision Optimax Sdn Bhd · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jun 8, 2018 as substantially equivalent to K112302 (CooperVision, Inc., 2011) and 1 other predicate after a 56-day review. Its family tree reaches back 6 generations to 2001. 1 later device descends from it.
- Decided
- Jun 8, 2018
- Review
- 56 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K003136 (2001). 14 ancestors in all, the oldest K952152 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK003136 Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily…Ocular Sciences Puerto Rico, Inc. · 2001
- 5 generations backK020389 Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact LensOcular Sciences · 2002
- 4 generations backK061948 Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc. · 2006 · Recalled
- 3 generations backK110099 Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear…CooperVision, Inc. · 2011
- 2 generations backK112302 Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal…CooperVision, Inc. · 2011
- 1 generation backK162223 Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Supervision Optimax Sdn Bhd · 2017
- This deviceK180985 Aveo (omafilcon A) Soft (Hydrophilic) Contact LensesSupervision Optimax Sdn Bhd · 2018
- Descendant · cites it directly · 0 of its ownK253885 PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC)…Geo Medical CO., LTD. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON…Geo Medical CO., LTD. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003136 | Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily Wear Soft… | Ocular Sciences Puerto Rico, Inc. | 2001 | — |
| −5 | K020389 | Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens | Ocular Sciences | 2002 | — |
| −4 | K061948 | Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens | CooperVision, Inc. | 2006 | 1 |
| −3 | K110099 | Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft… | CooperVision, Inc. | 2011 | — |
| −2 | K112302 | Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear… | CooperVision, Inc. | 2011 | — |
| −1 | K162223 | Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) | Supervision Optimax Sdn Bhd | 2017 | — |
| 0 (this device) | K180985 | Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses | Supervision Optimax Sdn Bhd | 2018 | — |
| +1 | K253885 | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS… | Geo Medical CO., LTD. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K112302 | Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere &…Summary page 4…(Hydrophilic) Contact Lens 510(k) Number K112302 K162223 Regulation Number 21 CFR 886.5925 21CFR 886.5925 Regulatory Name… | 2011 |
| * | K162223 | Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Summary page 4…(Hydrophilic) Contact Lens 510(k) Number K112302 K162223 Regulation Number 21 CFR 886.5925 21CFR 886.5925 Regulatory Name Soft (hydrophilic)… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253885 | PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON… | 2026 | 0 |
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 17 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K253885 (Geo Medical CO., LTD., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K112302.
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. 2018, this device’s year, is highlighted.
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?
Aveo (omafilcon A) Aspheric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity. Aveo ( omafilcon A) Toric Soft ( Hydrophilic) Contact Lenses are indicated the daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes…
Read the full statement (186 words)
Aveo (omafilcon A) Aspheric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity.
Aveo ( omafilcon A) Toric Soft ( Hydrophilic) Contact Lenses are indicated the daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of between 0.50D and 2.50D or less that does not interfere with visual acuity.
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent Planned Replacement Wear
When prescribed for frequent planned replacement wear the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.
Disposable Wear
When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180985 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180985: Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180985
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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