510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss (Clear & Blue Visibility Tinted, Lathe-Cut FR)

K981252510(k) TraditionalCleared Jun 23, 199878-day reviewClass II21 CFR 886.5925Recalls 2

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

Alden Optical Labs., Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Jun 23, 1998 as substantially equivalent to K964528 (Benz Research and Development Corp., 1997) after a 78-day review. Its family tree reaches back 1 generation to 1997. 6 later devices descend from it. It has been recalled 2 times.

Decided
Jun 23, 1998
Review
78 days
Class
Class II
Product code
LPL
Recalls
2
Predicates
1

Its longest line of descent runs back 1 generation to K964528 (1997). 6 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2006: 1 descendant cleared2014: 1 descendant cleared1999: 1 descendant cleared2004: 1 descendant cleared2002: 1 descendant clearedK964528 · (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue Tint · Benz Research and Development Corp. · 19971995200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants K964528 · (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue Tint · Benz Research and Development Corp. · 19970
  1. Root · 1 generation backK964528 (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft…Benz Research and Development Corp. · 1997
  2. This deviceK981252 Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact…Alden Optical Labs., Inc. · 1998
  3. Descendant · cites it directly · 3 of its ownK983278 Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear…Alden Optical Labs., Inc. · 1998
  4. Descendant · 2 generations on · 2 of its ownK992950 Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp. · 1999
  5. Descendant · cites it directly · 0 of its ownK133403 Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear…Firestone Optics, Inc. · 2014
  6. Descendant · cites it directly · 0 of its ownK060821 Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact LensesSpecialeyes, LLC · 2006
  7. Descendant · 3 generations on · 0 of its ownK041700 Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily…Cantor & Nissel, Ltd. · 2004

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12002: 12004: 12006: 12014: 1
1998high 1 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 6 · See all
  • K983278Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted…Alden Optical Labs., Inc. · 1998 · cites it directly3descendants
  • K992950Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp. · 1999 · 2 generations on2descendants
  • K133403Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses…Firestone Optics, Inc. · 2014 · cites it directly0descendants
  • K060821Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact LensesSpecialeyes, LLC · 2006 · cites it directly0descendants
  • K041700Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily WearCantor & Nissel, Ltd. · 2004 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K964528(Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic)…Benz Research and Development Corp.1997—
0 (this device)K981252Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss…Alden Optical Labs., Inc.1998—
+1K983278Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact…Alden Optical Labs., Inc.1998—
+2K992950Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp.1999—
+1K133403Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact…Firestone Optics, Inc.2014—
+1K060821Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact LensesSpecialeyes, LLC2006—
+3K041700Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily WearCantor & Nissel, Ltd.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200210
200410
200610
201410
FIG. 1 — Lineage of K981252, 1997–2014Source: 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? (4)

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
*K964528(Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses…
Summary page 3
…atories. The established safety profile (pre- clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 3X (hioxifilcon B), 510(k) #K964528. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate…
Benz Research and Development Corp.1997—
*—Alden Classic
Named without a submission number
—
*—Satureyes
Named without a submission number
—
*—Satureyes Toric
Named without a submission number
—

Also cleared against K964528: 10 other devices →

What descends from it? (6)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K983278Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted…Alden Optical Labs., Inc.19983
K133403Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses…Firestone Optics, Inc.20140
K060821Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact LensesSpecialeyes, LLC20060

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Nov 3, 2017Class IIZ-0984-2018Process designContact lenses lack sterility assurance.
Nov 3, 2017Class IIZ-0987-2018Process designContact lenses lack sterility assurance.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K983278 (Alden Optical Labs., Inc., 1998) has gone furthest, with 3 descendants of its own.
  • 10 other devices also cite its predicate K964528.

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.

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?

The OXYLENS (hioxifilcon B) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The OXYLENS (hioxifilcon B) Toric Soft Contact Lenses for daily wear are indicated for the…

Read the full statement (114 words)

The OXYLENS (hioxifilcon B) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

The OXYLENS (hioxifilcon B) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 Diopters.

The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K964528

10 other devices cite the same predicate.

  • K150590CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B)…Contamac, Ltd. · 2015
  • K120756LSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH (Mangofilcon a) Multifocal Soft…The Lagado Corp. · 2013
  • K073621Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue Visibility TintArt Optical Contact Lens, Inc. · 2008
  • K080686Westcon Horizon 49% (Hioxifilcon B)Westcon Contact Lens Co. · 2008
  • K060821Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact LensesSpecialeyes, LLC · 2006
  • K024045Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)Contamac, Ltd. · 2003

More from Alden Optical Labs., Inc.

11 FDA decisions under this applicant name. See the company

  • K133079IO2 Spher (Mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,IO2 Toric (Mangofilcon a) Soft…Alden Optical Labs., Inc. · 2013
  • K102557Novakone Spherical and Toric LensesAlden Optical Labs., Inc. · 20112 recalls
  • K091327Alden HP 54 Sphee 7 Hip 54 Toric Contact Lenses, Alden HP 54 Multifocal &HP 54 Toric Multifocal Contact LensesAlden Optical Labs., Inc. · 20102 recalls
  • K052703Alden Classic (Polymacon) Multifocal (Spherical and Toric), Alden Classic 55 (Methafilcon a) Multifocal…Alden Optical Labs., Inc. · 20051 recall
  • K042242Alden HP (Hioxifilcon B) Sphere & Toric Soft Contact LensesAlden Optical Labs., Inc. · 20043 recalls

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/K981252 · printed Nov 5, 2026

Cite this page

510(k) Report. “K981252: Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss (Clear & Blue Visibility Tinted, Lathe-Cut FR).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981252

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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