510(k) Report

510(k) · Cleared

Cleared

Contaflex GM3 58% (Acofilcon a) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)

K023349510(k) TraditionalCleared Dec 24, 200278-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

Contamac, Ltd. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Dec 24, 2002 as substantially equivalent to K952620 (Benz Research and Development Corp., 1995) after a 78-day review. Its family tree reaches back 1 generation to 1995. 35 later devices descend from it.

Decided
Dec 24, 2002
Review
78 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K952620 (1995). 35 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2008: 1 descendant cleared2010: 4 descendants cleared2019: 1 descendant cleared2012: 4 descendants cleared2015: 2 descendants cleared2023: 1 descendant cleared2014: 1 descendant cleared2011: 2 descendants cleared2024: 6 descendants cleared2016: 3 descendants cleared2017: 3 descendants cleared2021: 2 descendants cleared2018: 2 descendants cleared2025: 2 descendants clearedK952620 · Optical Blanks: BENZ55G Clear and Visibility Tinted · Benz Research and Development Corp. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 11 descendants5 generations forward: 5 descendants6 generations forward: 4 descendants7 generations forward: 5 descendants8 generations forward: 2 descendants9 generations forward: 4 descendants10 generations forward: 1 descendant K952620 · Optical Blanks: BENZ55G Clear and Visibility Tinted · Benz Research and Development Corp. · 19950+5+10
  1. Root · 1 generation backK952620 Optical Blanks: BENZ55G Clear and Visibility TintedBenz Research and Development Corp. · 1995
  2. This deviceK023349 Contaflex GM3 58% (Acofilcon a) Spherical Soft Contact Lens for…Contamac, Ltd. · 2002
  3. Descendant · cites it directly · 34 of its ownK024045 Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for…Contamac, Ltd. · 2003
  4. Descendant · 2 generations on · 33 of its ownK073621 Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon…Art Optical Contact Lens, Inc. · 2008
  5. Descendant · 3 generations on · 32 of its ownK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
  6. Descendant · 4 generations on · 12 of its ownK142641 Intelliwave4Art Optical Contact Lens, Inc. · 2015
  7. Descendant · 5 generations on · 11 of its ownK152046 Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact…Art Optical Contact Lens, Inc. · 2015

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2003: 12008: 12010: 42011: 22012: 42014: 12015: 22016: 32017: 32018: 22019: 12021: 22023: 12024: 62025: 2
2003high 6 (2024) · low 0 (2004)2026

Most influential descendants

Showing 5 of 35 · See all
  • K024045Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and…Contamac, Ltd. · 2003 · cites it directly34descendants
  • K073621Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear and Blue…Art Optical Contact Lens, Inc. · 2008 · 2 generations on33descendants
  • K100221INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010 · 3 generations on32descendants
  • K142641Intelliwave4Art Optical Contact Lens, Inc. · 2015 · 4 generations on12descendants
  • K152046Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilcon A)Art Optical Contact Lens, Inc. · 2015 · 5 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K952620Optical Blanks: BENZ55G Clear and Visibility TintedBenz Research and Development Corp.1995—
0 (this device)K023349Contaflex GM3 58% (Acofilcon a) Spherical Soft Contact Lens for Daily Wear…Contamac, Ltd.2002—
+1K024045Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear…Contamac, Ltd.2003—
+2K073621Intelliwave, Soft Daily Wear Contact Lens (Acofilcon B) Hioxifilcon B) Clear…Art Optical Contact Lens, Inc.2008—
+3K100221INTELLIWAVE3Art Optical Contact Lens, Inc.2010—
+4K142641Intelliwave4Art Optical Contact Lens, Inc.2015—
+5K152046Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens…Art Optical Contact Lens, Inc.2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200810
201040
201120
201240
201410
201520
201630
201730
201820
201910
202120
202310
202460
202520
FIG. 1 — Lineage of K023349, 1995–2025Source: 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
*K952620Optical Blanks: BENZ55G Clear and Visibility Tinted
Summary page 2
…ly equivalent to the following predicate device Predicate device: “BENZ 55G” manufactured/distributed by Benz Research and Development 5 1O(k) number; K952620 Device Description: The CONTAFLEX GM3 58% Spherical SoR Contact Lenses are fabricated from acofilcon A, which in the dry (unhy…
Benz Research and Development Corp.1995—

Also cleared against K952620: 2 other devices →

What descends from it? (35)

See all 35

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

NumberDeviceApplicantDecidedDescendants
K024045Contaflex GM3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and…Contamac, Ltd.200334

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, K024045 (Contamac, Ltd., 2003) has gone furthest, with 34 descendants of its own.
  • 2 other devices also cite its predicate K952620.

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 CONTAFLEX GM3 58 (acofilcon A) 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 .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system. Eyecare practitioners may…

Read the full statement (106 words)

The CONTAFLEX GM3 58 (acofilcon A) 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 .75 diopters or less where the astigmatism does not interfere with visual acuity.

The lens may be disinfected using a chemical disinfecting system.

Eyecare practitioners may prescribe the lenses for frequendplanned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for fiequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Indications for use as stated in the FDA summary.

Also cleared against K952620

2 other devices cite the same predicate.

  • K992589Resolution 5X (Spherical) and Ultra Gel 5X (Toric)(Hioxifilcon a) Soft Daily Wear Contact Lens, (Clear &…Opti-Centre Laboratories · 1999
  • K981779Cantor & Silver 5X (Hioxifilcon a) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Blue Visibility…Cantor & Silver, Ltd. · 1998

More from Contamac, Ltd.

21 FDA decisions under this applicant name. See the company

  • P240045Optimum Infinite (tisilfocon A) Orthokeratology Lenses IIContamac, Ltd. · 2026
  • K212631Optimum Infinite (tisilfocon A) Daily Wear Contact LensesContamac, Ltd. · 2022
  • K182304Hyper GP (tisilfocon A) Daily Wear Contact LensContamac, Ltd. · 2018
  • K181566NutrifillContamac, Ltd. · 20182 recalls
  • K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact LensContamac, Ltd. · 2018

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/K023349 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023349: Contaflex GM3 58% (Acofilcon a) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023349

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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