510(k) Report

510(k) · Cleared

Cleared

Safi-Gel Daily Disposable (Methafilcon a) Soft (Hydrophilic) Contact Lens, Safi-Gel Daily Disposable Toric ( Methafilcon

K090806510(k) TraditionalCleared Dec 18, 2009268-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

Safilens, S.R.L. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Dec 18, 2009 as substantially equivalent to K051095 (Optical Connection, Inc., 2005) after a 268-day review. Its family tree reaches back 1 generation to 2005. 12 later devices descend from it.

Decided
Dec 18, 2009
Review
268 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K051095 (2005). 12 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2013: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2018: 1 descendant cleared2020: 1 descendant cleared2019: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant clearedK051095 · 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear · Optical Connection, Inc. · 200520052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 4 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K051095 · 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear · Optical Connection, Inc. · 20050+5
  1. Root · 1 generation backK051095 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearOptical Connection, Inc. · 2005
  2. This deviceK090806 Safi-Gel Daily Disposable (Methafilcon a) Soft (Hydrophilic) Contact…Safilens, S.R.L. · 2009
  3. Descendant · cites it directly · 11 of its ownK121201 Savie-Aqua 55UV (Methafilcon a) Tinnted Blue Soft (Hydrophilic)…St. shine Optical Co., Ltd. · 2012
  4. Descendant · 2 generations on · 7 of its ownK162317 Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact…St. shine Optical Co., Ltd. · 2016
  5. Descendant · 3 generations on · 4 of its ownK200296 Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic)…Pegavision Corporation · 2020
  6. Descendant · 4 generations on · 2 of its ownK211448 Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation · 2021
  7. Descendant · 2 generations on · 2 of its ownK132146 Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic)…St. shine Optical Co., Ltd. · 2013

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12016: 12017: 12018: 12019: 12020: 12021: 12022: 12024: 12025: 12026: 1
2012high 1 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 12 · See all
  • K121201Savie-Aqua 55UV (Methafilcon a) Tinnted Blue Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd. · 2012 · cites it directly11descendants
  • K162317Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors…St. shine Optical Co., Ltd. · 2016 · 2 generations on7descendants
  • K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation · 2020 · 3 generations on4descendants
  • K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax…Pegavision Corporation · 2021 · 4 generations on2descendants
  • K132146Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact Lens…St. shine Optical Co., Ltd. · 2013 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K05109555 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearOptical Connection, Inc.2005—
0 (this device)K090806Safi-Gel Daily Disposable (Methafilcon a) Soft (Hydrophilic) Contact Lens…Safilens, S.R.L.2009—
+1K121201Savie-Aqua 55UV (Methafilcon a) Tinnted Blue Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd.2012—
+2K162317Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens…St. shine Optical Co., Ltd.2016—
+3K200296Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact…Pegavision Corporation2020—
+4K211448Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses…Pegavision Corporation2021—
+2K132146Saview-Aqua 58 UV (Etafilcon a) Visibility Tinted Soft (Hydrophilic) Contact…St. shine Optical Co., Ltd.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201610
201710
201810
201910
202010
202110
202210
202410
202510
202610
FIG. 1 — Lineage of K090806, 2005–2026Source: 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
*K05109555 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear
Summary page 1
…Wear, cleared for (hydrophilic) Lens for Daily KO051095. 1(090806 vesponse Page 19 of 26…
Optical Connection, Inc.2005—

Also cleared against K051095: 5 other devices →

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K121201Savie-Aqua 55UV (Methafilcon a) Tinnted Blue Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd.201211

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?

  • Its one ancestor has no recall.
  • Of its descendants, K121201 (St. shine Optical Co., Ltd., 2012) has gone furthest, with 11 descendants of its own.
  • 5 other devices also cite its predicate K051095.

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. 2009, 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 Safi-gel Daily Disposable (mnethafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or comeal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Safi-gel Daily Disposable Multifoical (metharilcon A) Soft (Hydrophilic) Contact Lens is…

Read the full statement (163 words)

The Safi-gel Daily Disposable (mnethafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or comeal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The Safi-gel Daily Disposable Multifoical (metharilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The Safi-gel Daily Disposable Toric (metharilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not aphakic persons with non diseased eyes.

The Safi-gel Daily Disposable Lenses are to be prescribed for single-use disposable wear, and are to be discarded after each removal.

Indications for use as stated in the FDA summary.

Also cleared against K051095

5 other devices cite the same predicate.

  • K240477Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric…St. shine Optical Co., Ltd. · 2024
  • K181558Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact…Gelflex Laboratories · 2018
  • K121201Savie-Aqua 55UV (Methafilcon a) Tinnted Blue Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd. · 2012
  • K092852Saview 58 UV; Toric & Multifocal (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily WearSt. shine Optical Co., Ltd. · 2010
  • K080794Polyvue 55 Single Vision, Toric and Multifocal Soft (Hydrophilic) Contact Lens for Daily WearPolyvue Distribution, Inc. · 2008

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/K090806 · printed Nov 3, 2026

Cite this page

510(k) Report. “K090806: Safi-Gel Daily Disposable (Methafilcon a) Soft (Hydrophilic) Contact Lens, Safi-Gel Daily Disposable Toric ( Methafilcon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090806

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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