510(k) Report

510(k) · Cleared

Cleared

IO2 Spher (Mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,IO2 Toric (Mangofilcon a) Soft (Hydrophilic)

K133079510(k) TraditionalCleared Dec 17, 201378-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

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

Cleared on Dec 17, 2013 as substantially equivalent to K120756 (The Lagado Corp., 2013) after a 78-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.

Decided
Dec 17, 2013
Review
78 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K964528 (1997). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2015: 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. · 1997K120756 · LSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH (Mangofilcon a) Multifocal Soft (Hydrophilic) Contact LE · The Lagado Corp. · 20131995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K120756 · LSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH (Mangofilcon a) Multifocal Soft (Hydrophilic) Contact LE · The Lagado Corp. · 2013K964528 · (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 · 2 generations backK964528 (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft…Benz Research and Development Corp. · 1997
  2. 1 generation backK120756 LSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH…The Lagado Corp. · 2013
  3. This deviceK133079 IO2 Spher (Mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily…Alden Optical Labs., Inc. · 2013
  4. Descendant · cites it directly · 0 of its ownK142820 BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for…Abb Optical Group, LLC · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K142820BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS…Abb Optical Group, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K964528(Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic)…Benz Research and Development Corp.1997—
−1K120756LSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH (Mangofilcon…The Lagado Corp.2013—
0 (this device)K133079IO2 Spher (Mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,IO2…Alden Optical Labs., Inc.2013—
+1K142820BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear…Abb Optical Group, LLC2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K133079, 1997–2015Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K120756LSH (Mangofilcon a) Sphere Soft (Hydrophilic) Contact Lens, LSH (Mangofilcon a)…
Summary page 4
…4 === V. Comparison to Legally Marketed Predicate L S anz,ofilg:on A) LSH (mangofilcon A) . S L R B bject déVica): ;" (predicate device) - Marketmg Status Not Yet Cleared K 120756 USAN Mangofilcon A Mangofilcon A Device Class 1 11 FDA Product Code LPL LPL Regulation 21 CFR 886.5925 21 CFR 886.5925 Intended U…
The Lagado Corp.2013—

Also cleared against K120756: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K142820BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS…Abb Optical Group, LLC20150

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 16 years and passes through 3 companies; a new generation was cleared every 16.2 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K142820 (Abb Optical Group, LLC, 2015) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K120756.

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. 2013, 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?

The iO; Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D. The ASTERA Multifecal iO, (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in…

Read the full statement (227 words)

The iO; Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D.

The ASTERA Multifecal iO, (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +30.00 to -30.00 D and have near add requirements up to 3.25 D.

The iOzToric (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or non-aphakic persons with non diseased eyes in a spherical power range of +30.00 to -30.00 D and a cylinder power range up to -10.0D.

The ASTERA Multifocal Toric iO; (mangofilcon A) Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic or non-aphakic patients with non-diseased eyes in a spherical power range of +30.00 to -30.00 D, a cylinder power range up to -10.00 D and an add requirement up to 3.25 D.

i0, lenses may be disinfected using chemical (not heat) disinfecting systems.

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 K120756

1 other device cites the same predicate.

  • K142820BIOLENS Sphere (mangofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, BIOLENS Toric (mangofilcon A)…Abb Optical Group, LLC · 2015

More from Alden Optical Labs., Inc.

11 FDA decisions under this applicant name. See the company

  • 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
  • K983278Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted an Non-Sighted Eyes)Alden Optical Labs., Inc. · 1998

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/K133079 · printed Nov 5, 2026

Cite this page

510(k) Report. “K133079: IO2 Spher (Mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,IO2 Toric (Mangofilcon a) Soft (Hydrophilic).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133079

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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