510(k) Report

510(k) · Cleared

Cleared

Ocu-Flex-53 Thin Zone Toric and Thin Zone Toric Aspherical (Ocufilcon) Soft Contact Lenses for Daily Wear

K003996510(k) TraditionalCleared Feb 21, 200157-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

Ocu-Ease Optical Products, Inc. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Feb 21, 2001 after a 57-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Feb 21, 2001
Review
57 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K003996Source: FDA 510(k) database · 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), 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

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.

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—

More from Ocu-Ease Optical Products, Inc.

17 FDA decisions under this applicant name. See the company

  • K023077Ocu-Flex Pediatric Aphakic (Ocufilcon B) Spherical Soft Contact Lens for Daily Wear (Lathe-Cut)Ocu-Ease Optical Products, Inc. · 2002
  • K020690Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact LensOcu-Ease Optical Products, Inc. · 2002
  • K011577Ocu-Flex 55 Spherical, Toric,Thin Zone Toric,Aspherical,Toric Aspherical and Thin Zone Toric Aspherical…Ocu-Ease Optical Products, Inc. · 2001
  • K004000Ocu-Flex-49 Thin Zone Toric and Thin Z0NE Toric Aspherical (Hioxifilcon B) Soft Contact Lenses for Daily…Ocu-Ease Optical Products, Inc. · 2001
  • K002966Ocu-Flex-49 Spherical, Toric, Aspherical and Toric Aspherical (Hioxifilcon B) Soft Contact Lenses for Daily…Ocu-Ease Optical Products, Inc. · 2000

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/K003996 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003996: Ocu-Flex-53 Thin Zone Toric and Thin Zone Toric Aspherical (Ocufilcon) Soft Contact Lenses for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003996

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026