510(k) · Cleared
ClearedTangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tangible Science, LLC · LPL Lenses, Soft Contact, Daily Wear
Cleared on Dec 13, 2017 as substantially equivalent to K141917 (Unicon Optical Co., Ltd., 2014) and 1 other predicate after a 98-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Dec 13, 2017
- Review
- 98 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K962804 (1996). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK962804 Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV…Vistakon, Johnson & Johnson Vision Products, Inc. · 1996
- 5 generations backK991134 Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 1999
- 4 generations backK994324 Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and…Vistakon, Johnson & Johnson Vision Products, Inc. · 2000
- 3 generations backK013973 Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear…Vistakon · 2002
- 2 generations backK051900 Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint…Johnson & Johnson Vision Care, Inc. · 2005 · Recalled
- 1 generation backK141917 Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker…Unicon Optical Co., Ltd. · 2014
- This deviceK172692 Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft…Tangible Science, LLC · 2017
- Descendant · cites it directly · 0 of its ownK182734 Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic)…Unicon Optical Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K182734Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable…Unicon Optical Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962804 | Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker | Vistakon, Johnson & Johnson Vision Products, Inc. | 1996 | — |
| −5 | K991134 | Acuvue (Etafilcon a)Soft (Hydrophilic) Contact Lenses, Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 1999 | — |
| −4 | K994324 | Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility… | Vistakon, Johnson & Johnson Vision Products, Inc. | 2000 | — |
| −3 | K013973 | Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted… | Vistakon | 2002 | — |
| −2 | K051900 | Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV… | Johnson & Johnson Vision Care, Inc. | 2005 | 2 |
| −1 | K141917 | Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily… | Unicon Optical Co., Ltd. | 2014 | — |
| 0 (this device) | K172692 | Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily… | Tangible Science, LLC | 2017 | — |
| +1 | K182734 | Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily… | Unicon Optical Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K141917 | Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily WearSummary page 5…e devices: • “UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear” By UNICON Optical Co., LTD. 510(k) number; K141917 Primary Predicate • “Saview-Aqua 58 UV (etafilcon A) Visibility Tinted Soft (Hydrophilic)… | 2014 |
| * | K132146 | Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact Lens…Summary page 5…• “Saview-Aqua 58 UV (etafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens” By St. Shine Optical Co., Ltd. 510(k) number; K132146 Reference Predicate Device Description: The Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophi… | 2013 |
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 |
|---|---|---|---|
| K182734 | Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable… | 2019 | 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 21 years and passes through 5 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K182734 (Unicon Optical Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K141917.
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. 2017, 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 Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. The Tangible Hydrogel with Tangible Polymer (etafilcon A) TORIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of…
Read the full statement (164 words)
The Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.
The Tangible Hydrogel with Tangible Polymer (etafilcon A) TORIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 5.00 D or less of astigmatism.
The Tangible Hydrogel with Tangible Polymer (etafilcon A) MULTIFOCAL Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 2.50 D of ADD power and may have 1.00 D or less of astigmatism.
Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172692 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172692: Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable 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/K172692
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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