510(k) Report

510(k) · Cleared

Cleared

eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K

K181579510(k) TraditionalCleared Jul 26, 201841-day reviewClass II21 CFR 886.5916

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

E&E Optics, Inc. · HQD Lens, Contact (Other Material) - Daily

Cleared on Jul 26, 2018 as substantially equivalent to K001960 (Polymer Technology, 2000) and 4 other predicates after a 41-day review. Its family tree reaches back 5 generations to 1994.

Decided
Jul 26, 2018
Review
41 days
Class
Class II
Product code
HQD
Recalls
None
Predicates
5

Its longest line of descent runs back 5 generations to K943177 (1994). 16 ancestors in all, the oldest P860022 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2017: 1 other ancestor2007: 1 other ancestor2001: 2 other ancestors2000: 2 other ancestors2002: 3 other ancestors1987: 1 other ancestorK943177 · Boston (R) 7 - 30(Enflufocon a) · Polymer Technology Corp. · 1994 · recalledK000795 · Rigid Gas Permeable Contact Lens · Polymer Technology · 2000K020006 · Dyna Intra-Limbal Lens · Lens Dynamics, Inc. · 2002K053124 · Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas Permeable Contact Lenses · Bausch & Lomb, Incorporated · 2006K071043 · Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a) Rigid Gas Permeable Contact Lenses · Bausch & Lomb, Inc. · 2007 · recalled19851990199520002005201020152020
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors3 generations back: 3 other ancestors K071043 · Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a) Rigid Gas Permeable Contact Lenses · Bausch & Lomb, Inc. · 2007 · recalledK053124 · Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas Permeable Contact Lenses · Bausch & Lomb, Incorporated · 2006K020006 · Dyna Intra-Limbal Lens · Lens Dynamics, Inc. · 2002K000795 · Rigid Gas Permeable Contact Lens · Polymer Technology · 2000K943177 · Boston (R) 7 - 30(Enflufocon a) · Polymer Technology Corp. · 1994 · recalled−50
  1. Root · 5 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
  2. 4 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
  3. 3 generations backK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
  4. 2 generations backK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
  5. 1 generation backK071043 Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES…Bausch & Lomb, Inc. · 2007 · Recalled
  6. This deviceK181579 eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid…E&E Optics, Inc. · 2018
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K943177Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp.19941
−4K000795Rigid Gas Permeable Contact LensPolymer Technology2000—
−3K020006Dyna Intra-Limbal LensLens Dynamics, Inc.2002—
−2K053124Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)…Bausch & Lomb, Incorporated2006—
−1K071043Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a)…Bausch & Lomb, Inc.20072
0 (this device)K181579eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas…E&E Optics, Inc.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
200020
200120
200230
200710
201710
FIG. 1 — Lineage of K181579, 1994–2018Source: 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 HQD? 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 HQD device

  1. #1 K240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas…score 19.4 · 12 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? (5)

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
*K001960Rigid Gas Permeable Contact Lens
Summary page 5
… “Boston XO (hexafocon A) Contact Lens for Daily Wear Orthokeratology” By Bausch + Lomb Inc. 510(k) number; K001960  “Boston Equalens II (oprifocon A) Contact Lens for Daily Wear Orthokeratology” By Ba…
Polymer Technology2000—
*K003933Boston Equalens II (Oprifocon a) Contact Lens for Orthokeratolgy
Summary page 5
… “Boston Equalens II (oprifocon A) Contact Lens for Daily Wear Orthokeratology” By Bausch + Lomb Inc. 510(k) number; K003933  “Boston XO2 (hexafocon B) Contact Lens for Daily Wear (Orthokeratology)” By Bausch +…
Polymer Technology2001—
*K071266Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens
Summary page 5
… “Boston XO2 (hexafocon B) Contact Lens for Daily Wear (Orthokeratology)” By Bausch + Lomb Inc. 510(k) number; K071266  “Boston XO (Hexafocon A) Rigid Gas Permeable Contact Lens” By Bausch + Lomb Inc.…
Bausch & Lomb, Inc.20072
*K071043Boston XO (Hexafocon a), Boston EO (Enflufocon B) and Boston ES (Enflufocon a) Rigid Gas…
Summary page 5
…071266  “Boston XO (Hexafocon A) Rigid Gas Permeable Contact Lens” By Bausch + Lomb Inc. 510(k) number; K071043  “Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens” By Acuity Polymers Inc.…
Bausch & Lomb, Inc.20072
*K170001Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
Summary page 5
…71043  “Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens” By Acuity Polymers Inc. 510(k) number; K170001 IV. DEVICE DESCRIPTION The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily…
Acuity Polymers, Inc.2017—

Also cleared against K001960: 1 other device →

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 24 years and passes through 6 companies; a new generation was cleared every 3.8 years on median.
  • 3 of the 15 ancestors have a recall of any class.
  • 1 other device also cites its predicate K001960.

How does its category compare?

All HQD devices

HQD Lens, Contact (Other Material) - Daily: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · HQD

5in 2024

2007: 42008: 52009: 22011: 22012: 22014: 12016: 72017: 92018: 52019: 22020: 12021: 32022: 32023: 32024: 52026 (partial year): 1
2007high 9 (2017) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQD

80in 2024

2007: 78 days median2008: 100 days median2016: 119 days median2017: 66 days median2018: 53 days median2021: 123 days median2022: 29 days median2023: 77 days median2024: 80 days median
2007high 123 (2021) · low 29 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HQD

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HQD

2in 2025

2007: 62008: 82009: 122010: 22011: 72012: 102013: 152014: 262015: 52016: 12017: 32019: 52020: 22021: 32022: 32023: 82024: 32025: 2
2007high 26 (2014) · low 0 (2018)2025

MAUDE reports naming product code HQD, 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
200747806
2008510008
20092—012
20100—12
20112—07
20122—010
20130—015
20141—026
20150—05
2016711901
201796603
201855300
20192—05
20201—02
2021312303
202232903
202337708
202458003
20250—02
20261—0—

What is it indicated for?

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid…

Read the full statement (161 words)

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lenses may be disinfected using a chemical disinfection system only.

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. The lenses may be disinfected using a chemical disinfection system only.

Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

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

Also cleared against K001960

1 other device cites the same predicate.

  • K071266Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 20072 recalls

Recent decisions in HQD

The HQD category page

  • K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd. · 2026
  • K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable…Acuity Polymers, Inc. · 2024
  • K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd. · 2024
  • K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A Bostonsight · 2024
  • K240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas…Acuity Polymers, Inc. · 2024

https://510kreport.com/device/K181579 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181579: eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181579

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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