510(k) · Cleared
ClearedSi-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visco Vision, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on May 26, 2016 as substantially equivalent to K073485 (Johnson & Johnson Vision Care, Inc., 2008) and 1 other predicate after a 108-day review. Its family tree reaches back 6 generations to 1981. 8 later devices descend from it.
- Decided
- May 26, 2016
- Review
- 108 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to P810005 (1981). 11 ancestors in all. 8 later devices descend from it, 6 citing it directly.
- Root · 6 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 5 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 4 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 3 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 2 generations backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- 1 generation backK141348 Visco Soft Contact LensVisco Vision, Inc. · 2015
- This deviceK160344 Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens…Visco Vision, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK193399 Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK180322 Si-Hy (olifilcon B) color silicone hydrogel soft contact lensVisco Vision, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK262495 Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK242056 miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily…Benq Materials Corporation · 2025
- Descendant · cites it directly · 0 of its ownK201080 Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft…Visco Vision, Inc. · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K193399Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2020 · cites it directly1descendant
- K180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lensVisco Vision, Inc. · 2018 · cites it directly1descendant
- K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026 · 2 generations on0descendants
- K242056miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color…Benq Materials Corporation · 2025 · 2 generations on0descendants
- K201080Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze…Visco Vision, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −5 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −4 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −3 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −2 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| −1 | K141348 | Visco Soft Contact Lens | Visco Vision, Inc. | 2015 | — |
| 0 (this device) | K160344 | Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy… | Visco Vision, Inc. | 2016 | — |
| +1 | K193399 | Miru 1day UpSide (midafilcon A) | Menicon Co, Ltd. | 2020 | — |
| +1 | K180322 | Si-Hy (olifilcon B) color silicone hydrogel soft contact lens | Visco Vision, Inc. | 2018 | — |
| +2 | K262495 | Miru 1day UpSide (midafilcon A) | Menicon Co, Ltd. | 2026 | — |
| +2 | K242056 | miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily… | Benq Materials Corporation | 2025 | — |
| +1 | K201080 | Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens… | Visco Vision, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2025 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K073485 | Vistakon (Narafilcon) a Soft Contact LensSummary page 4…CFR 886.5925, Product Code MVN) Classification II 5.4 Legally Marketed Equivalent Device: Indication Vistakon (narafilcon A), K073485, Product Code: MVN Johnson & Johnson Vision Care Inc. Material Visco (olifilcon A) soft contact lens,… | 2008 |
| * | K141348 | Visco Soft Contact LensSummary page 4…Vistakon (narafilcon A), K073485, Product Code: MVN Johnson & Johnson Vision Care Inc. Material Visco (olifilcon A) soft contact lens, K141348, Product Code: LPL/MVN Visco Vision Inc. page 1… | 2015 |
What descends from it? (8)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193399 | Miru 1day UpSide (midafilcon A) | 2020 | 1 |
| K180322 | Si-Hy (olifilcon B) color silicone hydrogel soft contact lens | 2018 | 1 |
| K201080 | Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze… | 2020 | 0 |
| K191397 | OxySoft (olifilcon C) silicone hydrogel soft contact lens | 2019 | 0 |
| K181349 | Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily… | 2018 | 0 |
| K173958 | OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon… | 2018 | 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 35 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K193399 (Menicon Co, Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K073485.
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. 2016, 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 Si-Hy Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity. The Si-Hy Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of…
Read the full statement (204 words)
The Si-Hy Spherical Silicone Hydrogel Soft Contact Lenses are indicated as daily wear single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Si-Hy Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.
The Si-Hy Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160344 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160344: Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160344
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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