510(k) Report

510(k) · Cleared

Cleared

Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact Lenses

K060821510(k) TraditionalCleared May 18, 200652-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

Specialeyes, LLC · LPL Lenses, Soft Contact, Daily Wear

Cleared on May 18, 2006 as substantially equivalent to K983773 (Benz Research and Development Corp., 1998) and 5 other predicates after a 52-day review. Its family tree reaches back 2 generations to 1997.

Decided
May 18, 2006
Review
52 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
6

Its longest line of descent runs back 2 generations to K964528 (1997). 6 ancestors in all, the oldest K953199 (1995). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestor1995: 1 other ancestorK964528 · (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. · 1997K981252 · Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss (Clear & Blue Visibility Tinted, Lathe-Cut FR) · Alden Optical Labs., Inc. · 1998 · recalled1996199820002002200420062008
Other ancestors, by generation 1 generation back: 4 other ancestors K981252 · Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss (Clear & Blue Visibility Tinted, Lathe-Cut FR) · Alden Optical Labs., Inc. · 1998 · recalledK964528 · (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 backK981252 Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact…Alden Optical Labs., Inc. · 1998 · Recalled
  3. This deviceK060821 Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact LensesSpecialeyes, LLC · 2006
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—
−1K981252Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss…Alden Optical Labs., Inc.19982
0 (this device)K060821Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact LensesSpecialeyes, LLC2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199710
199810
200410
FIG. 1 — Lineage of K060821, 1997–2006Source: 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? (6)

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
*K983773Benz G-5X (Hioxifilcon a) Soft Daily Wear Contact Lens
Summary page 2
…ferences between the proposed and predicate devices have been identified and explained in the Comparison Matrix which has been included in Section 9 of this submission. K983773 - BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS K964528 - BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT DAILY WEAR…
Benz Research and Development Corp.1998—
*K964528(Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses…
Summary page 2
…ns compatibility, preservation uptake tests and shelf life studies were completed on the predicate device, which is identical to the device proposed in this 5 10(k), see K964528. Substantial Equivallence to Predicate Device: SpecialEyes claims the proposed device to be substantially equivalent to the de…
Benz Research and Development Corp.1997—
*K042242Alden HP (Hioxifilcon B) Sphere & Toric Soft Contact Lenses
Summary page 2
…mission. K983773 - BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS K964528 - BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT DAILY WEAR CONTACT LENS K042242 - ALDEN HP SHPERE AND TORIC / OXYLENS K981252 - ALDEN HP SHPERE AND TORIC / OXYLENS K953199 - METRO OPTICS SATUREYES SPHEREICAL A…
Alden Optical Labs., Inc.20043
*K981252Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss (Clear & Blue…
Summary page 2
…SOFT DAILY WEAR CONTACT LENS K964528 - BENZ-G 3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT DAILY WEAR CONTACT LENS K042242 - ALDEN HP SHPERE AND TORIC / OXYLENS K981252 - ALDEN HP SHPERE AND TORIC / OXYLENS K953199 - METRO OPTICS SATUREYES SPHEREICAL AND TORIC K964902 - METRO OPTICS SATUREYES SPHE…
Alden Optical Labs., Inc.19982
*K953199Metro 55G Toric & Spherical
Summary page 2
…3X (HIOXIFILCON B) SPHERICAL AND TORIC SOFT DAILY WEAR CONTACT LENS K042242 - ALDEN HP SHPERE AND TORIC / OXYLENS K981252 - ALDEN HP SHPERE AND TORIC / OXYLENS K953199 - METRO OPTICS SATUREYES SPHEREICAL AND TORIC K964902 - METRO OPTICS SATUREYES SPHEREICAL AND TORIC DEPARTME…
Metrosoft, Inc.1995—
*K964902Contact Lenses Metro-G 3X (Hioxifilcon B)
Summary page 2
…CONTACT LENS K042242 - ALDEN HP SHPERE AND TORIC / OXYLENS K981252 - ALDEN HP SHPERE AND TORIC / OXYLENS K953199 - METRO OPTICS SATUREYES SPHEREICAL AND TORIC K964902 - METRO OPTICS SATUREYES SPHEREICAL AND TORIC DEPARTMENT OF HEALTH & HUMAN SERVICES…
Metro Optics of Austin, Inc.1997—

Also cleared against K983773: 1 other device →

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 9 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
  • 2 of the 6 ancestors have a recall of any class.
  • 1 other device also cites its predicate K983773.

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 Special Eyes 59 (hioxifilcon A) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with non-diseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities. The Special Eyes 49 (hioxifilcon B) Sphere and Toric soft contact lenses for daily…

Read the full statement (110 words)

The Special Eyes 59 (hioxifilcon A) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with non-diseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.

The Special Eyes 49 (hioxifilcon B) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with non-diseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.

Indications for use as stated in the FDA summary.

Also cleared against K983773

1 other device cites the same predicate.

  • K052290Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact LensClearlab Pte, Ltd. · 2006

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/K060821 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060821: Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060821

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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