510(k) · Cleared
ClearedUnicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unicon Optical Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Oct 17, 2014 as substantially equivalent to K051900 (Johnson & Johnson Vision Care, Inc., 2005) after a 94-day review. Its family tree reaches back 5 generations to 1996. 3 later devices descend from it.
- Decided
- Oct 17, 2014
- Review
- 94 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K962804 (1996). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 4 generations backK991134 Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 1999
- 3 generations backK994324 Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 2000
- 2 generations backK013973 Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear…Vistakon · 2002
- 1 generation backK051900 Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint…Johnson & Johnson Vision Care, Inc. · 2005 · Recalled
- This deviceK141917 Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker…Unicon Optical Co., Ltd. · 2014
- Descendant · cites it directly · 1 of its ownK172692 Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft…Tangible Science, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK182734 Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic)…Unicon Optical Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK171125 Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic)…Tangible Science, LLC · 2017
Most influential descendants
Showing 3 of 3 · See all- K172692Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily…Tangible Science, LLC · 2017 · cites it directly1descendant
- K182734Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable…Unicon Optical Co., Ltd. · 2019 · 2 generations on0descendants
- K171125Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact LensTangible Science, LLC · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −4 | K991134 | Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 1999 | — |
| −3 | K994324 | Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 2000 | — |
| −2 | K013973 | Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted… | Vistakon | 2002 | — |
| −1 | K051900 | Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV… | Johnson & Johnson Vision Care, Inc. | 2005 | 2 |
| 0 (this device) | K141917 | Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily… | Unicon Optical Co., Ltd. | 2014 | — |
| +1 | K172692 | Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily… | Tangible Science, LLC | 2017 | — |
| +2 | K182734 | Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily… | Unicon Optical Co., Ltd. | 2019 | — |
| +1 | K171125 | Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear… | Tangible Science, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 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 |
|---|---|---|---|
| * | K051900 | Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for…Summary page 4…Wear Manufacturer: VISTAKON Product Code: MVN烊LPL 510(k) Number: K051900 UNICON Optical Co., LTD. UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens 510(k) Notification, K14… | 2005 |
What descends from it? (3)
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 18 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K172692 (Tangible Science, LLC, 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K051900.
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. 2014, 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 UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear is indicated for the
correction of ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eye who may have
1.00 D or less astigmatism. The UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear
are single disposable wear and are to be discarded after each removal. UNICON (etafilcon A) Soft (hydrophilic) Contact
Lens with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into
the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141917 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141917: Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141917
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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