510(k) Report

510(k) · Cleared

Cleared

OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™

K241707510(k) SpecialCleared Jul 12, 202429-day reviewClass II21 CFR 886.5925

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Unicon Optical Co., Ltd. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Jul 12, 2024 as substantially equivalent to K213216 (Unicon Optical Co., Ltd., 2022) and 2 other predicates after a 29-day review. Its family tree reaches back 7 generations to 1981.

Decided
Jul 12, 2024
Review
29 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
3

Its longest line of descent runs back 7 generations to P810005 (1981). 14 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2022: 1 other ancestor2019: 1 other ancestor2016: 1 other ancestor2005: 1 other ancestor1999: 1 other ancestor1984: 1 other ancestor2001: 1 other ancestorP810005 · Weicon (R) (Tefilicon) Hydrophilic Contact Lens · Ciba Vision Care · 1981K970746 · SEE3 (Lotrafilcon a) Soft Contact Lens · Ciba Vision Corporation · 1997K020139 · Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design · Ciba Vision Corporation · 2002K033919 · Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs · Ciba Vision Corporation · 2004 · recalledK052560 · Biofinity (Comfilcon a) Soft Contact Lens · CooperVision, Inc. · 2005 · recalledK160212 · ACUVUE (senofilcon C) Soft Contact Lens · Johnson & Johnson Vision Care, Inc. · 2016 · recalledK213216 · Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens · Unicon Optical Co., Ltd. · 202219801990200020102020
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors5 generations back: 1 other ancestor6 generations back: 1 other ancestor K213216 · Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens · Unicon Optical Co., Ltd. · 2022K160212 · ACUVUE (senofilcon C) Soft Contact Lens · Johnson & Johnson Vision Care, Inc. · 2016 · recalledK052560 · Biofinity (Comfilcon a) Soft Contact Lens · CooperVision, Inc. · 2005 · recalledK033919 · Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs · Ciba Vision Corporation · 2004 · recalledK020139 · Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design · Ciba Vision Corporation · 2002K970746 · SEE3 (Lotrafilcon a) Soft Contact Lens · Ciba Vision Corporation · 1997P810005 · Weicon (R) (Tefilicon) Hydrophilic Contact Lens · Ciba Vision Care · 1981−50
  1. Root · 7 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
  2. 6 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
  3. 5 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
  4. 4 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
  5. 3 generations backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
  6. 2 generations backK160212 ACUVUE (senofilcon C) Soft Contact LensJohnson & Johnson Vision Care, Inc. · 2016 · Recalled
  7. 1 generation backK213216 Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact LensUnicon Optical Co., Ltd. · 2022
  8. This deviceK241707 OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with…Unicon Optical Co., Ltd. · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7P810005Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care1981—
−6K970746SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation1997—
−5K020139Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation2002—
−4K033919Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal…Ciba Vision Corporation20041
−3K052560Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc.20051
−2K160212ACUVUE (senofilcon C) Soft Contact LensJohnson & Johnson Vision Care, Inc.20161
−1K213216Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact LensUnicon Optical Co., Ltd.2022—
0 (this device)K241707OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™Unicon Optical Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199910
200110
200510
201610
201910
202210
FIG. 1 — Lineage of K241707, 1981–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K213216Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
Summary page 6
…wing predicate device(s):  “Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens” By Unicon Optical Co., Ltd. 510(k) number; K213216 Primary Predicate  “Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens” By Unicon Op…
Unicon Optical Co., Ltd.2022—
*K191929UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
Summary page 6
…Primary Predicate  “Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens” By Unicon Optical Co., Ltd. 510(k) number; K191929 Reference Predicate  “Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens” By…
Unicon Optical Co., Ltd.2019—
*K213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
Summary page 6
…Reference Predicate  “Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens” By Innova Vision Inc. 510(k) number; K213119 Reference Predicate IV. DEVICE DESCRIPTION The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSE…
Innova Vision, Inc.2022—

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 43 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
  • 5 of the 14 ancestors have a recall of any class.

How does its category compare?

All LPL devices

LPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · LPL

12in 2025

2007: 32008: 102009: 62010: 92011: 122012: 122013: 172014: 152015: 122016: 212017: 92018: 212019: 112020: 102021: 82022: 92023: 102024: 122025: 122026 (partial year): 10
2007high 21 (2016) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LPL

202in 2025

2007: 281 days median2008: 104 days median2009: 260 days median2010: 244 days median2011: 170 days median2012: 131 days median2013: 135 days median2014: 102 days median2015: 120 days median2016: 112 days median2017: 98 days median2018: 56 days median2019: 115 days median2020: 158 days median2021: 88 days median2022: 212 days median2023: 167 days median2024: 128 days median2025: 202 days median2026 (partial year): 90 days median
2007high 281 (2007) · low 56 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LPL

1in 2025

2007: 12009: 12011: 52012: 12014: 12015: 12017: 112020: 12022: 12025: 12026 (partial year): 1
2007high 11 (2017) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LPL

216in 2025

2007: 2802008: 2142009: 1372010: 2222011: 3772012: 2502013: 1512014: 1792015: 1612016: 1932017: 2802018: 2572019: 2052020: 1172021: 1102022: 1262023: 1782024: 2972025: 216
2007high 377 (2011) · low 110 (2021)2025

MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200732811280
2008101040214
200962601137
201092440222
2011121705377
2012121311250
2013171350151
2014151021179
2015121201161
2016211120193
201799811280
201821560257
2019111150205
2020101581117
20218880110
202292121126
2023101670178
2024121280297
2025122021216
202610901—

What is it indicated for?

OCuSOFT® AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity. OCuSOFT® AMENITY™ (linofilcon A) TORIC DAILY DISPOSABLE CONTACT LENSES with…

Read the full statement (211 words)

OCuSOFT® AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

OCuSOFT® AMENITY™ (linofilcon A) TORIC DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

OCuSOFT® AMENITY™ (linofilcon A) MULTIFOCAL DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Indications for use as stated in the FDA summary.

More from Unicon Optical Co., Ltd.

5 FDA decisions under this applicant name. See the company

  • K213216Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact LensUnicon Optical Co., Ltd. · 2022
  • K191929UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensUnicon Optical Co., Ltd. · 2019
  • K182734Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable ContacUnicon Optical Co., Ltd. · 2019
  • K141917Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily WearUnicon Optical Co., Ltd. · 2014

Recent decisions in LPL

The LPL category page

  • K253875OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric…Visco Vision, Inc. · 2026
  • K262941Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact LensBausch + Lomb, Inc. · 2026
  • K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd. · 2026
  • K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc. · 2026
  • K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft…Pegavision Corporation · 2026

https://510kreport.com/device/K241707 · printed Nov 5, 2026

Cite this page

510(k) Report. “K241707: OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K241707

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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