510(k) Report

PMA · Approved

Approved

Hydron (R) (Polymacon) Hydrophilic Contact Lenses

P910029/S001PMAApproved Jun 29, 1993379-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

Les Laboratories Blonchard · LPL Lenses, Soft Contact, Daily Wear

Approved on Jun 29, 1993 through premarket approval, which rests on the device’s own clinical evidence after a 379-day review. 4 later devices descend from it.

Decided
Jun 29, 1993
Review
379 days
Class
Class II
Product code
LPL
Recalls
None

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceP910029/S001 Hydron (R) (Polymacon) Hydrophilic Contact LensesLes Laboratories Blonchard · 1993
  2. Descendant · cites it directly · 3 of its ownK982904 Esstech Multi Aspheric (Multifocal) (Hioxifilcon B) Soft…Les Laboratoires Blanchard · 1998
  3. Descendant · 2 generations on · 2 of its ownK070308 Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and…X-Cel Contacts · 2007
  4. Descendant · 3 generations on · 1 of its ownK100443 Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 2010
  5. Descendant · 4 generations on · 0 of its ownK242059 Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact…X-Cel Specialty Contacts, A Walman Optical Company · 2024

Most influential descendants

Showing 4 of 4 · See all
  • K982904Esstech Multi Aspheric (Multifocal) (Hioxifilcon B) Soft (Hydrophilic) Contact LensLes Laboratoires Blanchard · 1998 · cites it directly3descendants
  • K070308Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily WearX-Cel Contacts · 2007 · 2 generations on2descendants
  • K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc. · 2010 · 3 generations on1descendant
  • K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)X-Cel Specialty Contacts, A Walman Optical Company · 2024 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)P910029/S001Hydron (R) (Polymacon) Hydrophilic Contact LensesLes Laboratories Blonchard1993—
+1K982904Esstech Multi Aspheric (Multifocal) (Hioxifilcon B) Soft (Hydrophilic) Contact…Les Laboratoires Blanchard1998—
+2K070308Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for…X-Cel Contacts2007—
+3K100443Definitive, Flexlens - Silicone HydrogelX-Cel Contacts, Inc.2010—
+4K242059Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens…X-Cel Specialty Contacts, A Walman Optical Company2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200710
201010
202410
FIG. 1 — Lineage of P910029/S001, 1993–2024Source: 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 PMA database (decision fields and supplements), 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

Does it have a predicate?

PMA decisions do not claim a predicate device.

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K982904Esstech Multi Aspheric (Multifocal) (Hioxifilcon B) Soft (Hydrophilic) Contact LensLes Laboratoires Blanchard19983

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?

  • Of its descendants, K982904 (Les Laboratoires Blanchard, 1998) has gone furthest, with 3 descendants of its own.

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 Les Laboratories Blonchard

2 FDA decisions under this applicant name. See the company

  • P910029/S002\Ydron (R) (Polymacon) Hydrophilic Contact LensesLes Laboratories Blonchard · 1993

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/P910029/S001 · printed Nov 6, 2026

Cite this page

510(k) Report. “P910029/S001: Hydron (R) (Polymacon) Hydrophilic Contact Lenses.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P910029/S001

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