510(k) Report

510(k) · Cleared

Cleared

SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens

K152657510(k) TraditionalCleared May 17, 2016244-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

Smart Performer Corp., Ltd. · LPL Lenses, Soft Contact, Daily Wear

Cleared on May 17, 2016 as substantially equivalent to K141280 (Seinoh Optical Co., Ltd., 2014) and 2 other predicates after a 244-day review. Its family tree reaches back 6 generations to 1994.

Decided
May 17, 2016
Review
244 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K942214 (1994). 14 ancestors in all, the oldest P890023 (1989). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 2 other ancestors1996: 1 other ancestor2002: 1 other ancestor1989: 1 other ancestor2000: 2 other ancestors1999: 1 other ancestorK942214 · H55 Hydrophilic Contact Lens · Martin S. Knopf Assoc., Inc. · 1994K972303 · Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact Lens · Ocular Sciences Puerto Rico, Inc. · 1997K984046 · Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens · Ocular Sciences Puerto Rico, Inc. · 1999K012425 · Biomedics UV Multifocal · Ocular Sciences Puerto Rico, Inc. · 2001K091339 · Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens · CooperVision, Inc. · 2010 · recalledK141280 · Ilens (Ocufilcon D) Daily Soft Contact Lens · Seinoh Optical Co., Ltd. · 20141985199019952000200520102015
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor3 generations back: 2 other ancestors4 generations back: 3 other ancestors K141280 · Ilens (Ocufilcon D) Daily Soft Contact Lens · Seinoh Optical Co., Ltd. · 2014K091339 · Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens · CooperVision, Inc. · 2010 · recalledK012425 · Biomedics UV Multifocal · Ocular Sciences Puerto Rico, Inc. · 2001K984046 · Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens · Ocular Sciences Puerto Rico, Inc. · 1999K972303 · Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact Lens · Ocular Sciences Puerto Rico, Inc. · 1997K942214 · H55 Hydrophilic Contact Lens · Martin S. Knopf Assoc., Inc. · 1994−50
  1. Root · 6 generations backK942214 H55 Hydrophilic Contact LensMartin S. Knopf Assoc., Inc. · 1994
  2. 5 generations backK972303 Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc. · 1997
  3. 4 generations backK984046 Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc. · 1999
  4. 3 generations backK012425 Biomedics UV MultifocalOcular Sciences Puerto Rico, Inc. · 2001
  5. 2 generations backK091339 Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc. · 2010 · Recalled
  6. 1 generation backK141280 Ilens (Ocufilcon D) Daily Soft Contact LensSeinoh Optical Co., Ltd. · 2014
  7. This deviceK152657 SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact LensSmart Performer Corp., Ltd. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K942214H55 Hydrophilic Contact LensMartin S. Knopf Assoc., Inc.1994—
−5K972303Oscular Sciences/ American Hydron, Inc Daily Wear Soft Contact LensOcular Sciences Puerto Rico, Inc.1997—
−4K984046Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac LensOcular Sciences Puerto Rico, Inc.1999—
−3K012425Biomedics UV MultifocalOcular Sciences Puerto Rico, Inc.2001—
−2K091339Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact LensCooperVision, Inc.20101
−1K141280Ilens (Ocufilcon D) Daily Soft Contact LensSeinoh Optical Co., Ltd.2014—
0 (this device)K152657SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact LensSmart Performer Corp., Ltd.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199610
199910
200020
200120
200210
FIG. 1 — Lineage of K152657, 1994–2016Source: 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? (3)

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
*K141280Ilens (Ocufilcon D) Daily Soft Contact Lens
Summary page 4
…Review Panel Ophthalmic Devices Predicate Device  iLens@ (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens, K141280, submitted by SEINOH OPTICAL CO. LTD. .  BIOMEDICS UV Colors (Ocufilcon D) Soft (hydrophilic) Contact Lens, K013377,…
Seinoh Optical Co., Ltd.2014—
*K013377Biomedics UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens
Summary page 4
…Daily Wear Soft (Hydrophilic) Contact Lens, K141280, submitted by SEINOH OPTICAL CO. LTD. .  BIOMEDICS UV Colors (Ocufilcon D) Soft (hydrophilic) Contact Lens, K013377, submitted by Ocular Sciences Inc.  ACUVUE 2 COLOURS Brand (etafilcon A) Contact Lens with UV blocker, K010114, sub…
Ocular Sciences Puerto Rico, Inc.2001—
*K010114Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted (to Mask or Enhance…
Summary page 4
…rs (Ocufilcon D) Soft (hydrophilic) Contact Lens, K013377, submitted by Ocular Sciences Inc.  ACUVUE 2 COLOURS Brand (etafilcon A) Contact Lens with UV blocker, K010114, submitted by VISTAKON, Division of Johnson & Johnson Vision Care, Inc. Page 1…
Johnson & Johnson Vision Care, Inc.2001—

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 22 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
  • 2 of the 14 ancestors have a recall of any class.

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. 2016, 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?

SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is intended to use as correction of refractive myopia in aphakic or non-aphakic persons with non-diseased eyes, who may have 1.00D of astigmatism or less. The lenses are available with a visibility-handling tint or with a decorative tint intended to enhance or alter the apparent color of the eye.

Eyecare practitioners may prescribe the contact lens for single-use disposable daily wear. The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lenses are not intended to be disinfected and should be discarded after a single use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Smart Performer Corp., Ltd.

2 FDA decisions under this applicant name. See the company

  • K151847SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact LensSmart Performer Corp., Ltd. · 2016

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/K152657 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152657: SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152657

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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