510(k) · Cleared
ClearedPUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSES
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Geo Medical CO., LTD. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Apr 29, 2026 as substantially equivalent to K180985 (Supervision Optimax Sdn Bhd, 2018) after a 146-day review. Its family tree reaches back 7 generations to 2001.
- Decided
- Apr 29, 2026
- Review
- 146 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K003136 (2001). 15 ancestors in all, the oldest K952152 (1995). No later device cites it as a predicate yet.
- Root · 7 generations backK003136 Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily…Ocular Sciences Puerto Rico, Inc. · 2001
- 6 generations backK020389 Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact LensOcular Sciences · 2002
- 5 generations backK061948 Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact LensCooperVision, Inc. · 2006 · Recalled
- 4 generations backK110099 Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear…CooperVision, Inc. · 2011
- 3 generations backK112302 Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal…CooperVision, Inc. · 2011
- 2 generations backK162223 Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)Supervision Optimax Sdn Bhd · 2017
- 1 generation backK180985 Aveo (omafilcon A) Soft (Hydrophilic) Contact LensesSupervision Optimax Sdn Bhd · 2018
- This deviceK253885 PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC)…Geo Medical CO., LTD. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003136 | Ocular Sciences, Inc. Biomedics 52 (Ocufilcon D) UV Blocking Daily Wear Soft… | Ocular Sciences Puerto Rico, Inc. | 2001 | — |
| −6 | K020389 | Biomedics 52 (Ocufilcon B) UV Blocking Daily Wear Soft Contact Lens | Ocular Sciences | 2002 | — |
| −5 | K061948 | Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens | CooperVision, Inc. | 2006 | 1 |
| −4 | K110099 | Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft… | CooperVision, Inc. | 2011 | — |
| −3 | K112302 | Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear… | CooperVision, Inc. | 2011 | — |
| −2 | K162223 | Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) | Supervision Optimax Sdn Bhd | 2017 | — |
| −1 | K180985 | Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses | Supervision Optimax Sdn Bhd | 2018 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K180985 | Aveo (omafilcon A) Soft (Hydrophilic) Contact LensesSummary page 6…vice: “Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses” By Supervision Optimax SDN BHD Primary Predicate 510(k) number; K180985 “Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens” By Innova Vision Inc. Ref… | 2018 |
| † | K222954 | Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens | 2023 |
| † | K200296 | Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 15 ancestors has a recall of any class.
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. 2026, 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?
The Puscon Water Balance-1Day Tint (omafilcon A) Soft (Hydrophilic) Contact Lens and Puscon Water Balance-1Day Color (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for single use for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia. The lenses may be worn by people who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lenses are available tinted and may be used to enhance or alter the apparent color of the eye. The lenses are to be discarded after each removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253885 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253885: PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (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/K253885
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026