510(k) Report

510(k) · Cleared

Cleared

Boston Equalens II (Oprifocon a) Contact Lens for Orthokeratolgy

K003933510(k) TraditionalCleared Feb 16, 200158-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

Polymer Technology · MUW Lens, Contact (Orthokeratology)

Cleared on Feb 16, 2001 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Feb 16, 2001
Review
58 days
Class
Class II
Product code
MUW
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared200020052010201520202025
  1. This deviceK003933 Boston Equalens II (Oprifocon a) Contact Lens for OrthokeratolgyPolymer Technology · 2001
  2. Descendant · cites it directly · 0 of its ownK181579 eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid…E&E Optics, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K181579eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact…E&E Optics, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003933Boston Equalens II (Oprifocon a) Contact Lens for OrthokeratolgyPolymer Technology2001—
+1K181579eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas…E&E Optics, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K003933, 2001–2018Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MUW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K181579eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact…E&E Optics, Inc.20180

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, K181579 (E&E Optics, Inc., 2018) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MUW devices

MUW Lens, Contact (Orthokeratology): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MUW

1in 2019

2016: 12019: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUW

Too few MUW 510(k)s in any year since 2007 to give a median.

Recalls per year · MUW

No recall names MUW since 2007.

Adverse event reports per year · MUW

1in 2023

2007: 12010: 12012: 12023: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code MUW, 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
20070—01
20080—00
20090—00
20100—01
20110—00
20120—01
20130—00
20140—00
20150—00
20161—00
20170—00
20180—00
20191—00
20200—00
20210—00
20220—00
20230—01
20240—00
20250—00
20260—0—

More from Polymer Technology

5 FDA decisions under this applicant name. See the company

  • K003932Boston EO (Enflufocon B) Contact Lens for OrthokeratolgyPolymer Technology · 2001
  • K002025Rigid Gas Permeable Contact LensPolymer Technology · 2000
  • K001960Rigid Gas Permeable Contact LensPolymer Technology · 2000
  • K000795Rigid Gas Permeable Contact LensPolymer Technology · 2000

Recent decisions in MUW

The MUW category page

  • K183200iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact LensesC&E GP Specialist, Inc. · 2019
  • K160859OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)Contamac, Ltd. · 2016
  • P870024/S045Fluoroperm 60 Rigid Gas Permeable Contact LensesCooperVision, Inc. · 2005
  • P870024/S044Paflufocon D Rigid Gas Permeable Contact LensesCooperVision, Inc. · 2004
  • K010109Fluoroperm 151-OK, Paragon HDS 100-OKParagon Vision Sciences · 2001

https://510kreport.com/device/K003933 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003933: Boston Equalens II (Oprifocon a) Contact Lens for Orthokeratolgy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003933

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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