510(k) Report

510(k) · Cleared

Cleared

Boston ES Multivision (Enflufocon a) Contact Lens

K970698510(k) TraditionalCleared May 6, 199770-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 Corp. · HQD Lens, Contact (Other Material) - Daily

Cleared on May 6, 1997 as substantially equivalent to K943177 (Polymer Technology Corp., 1994) and 1 other predicate after a 70-day review. Its family tree reaches back 1 generation to 1994. 30 later devices descend from it.

Decided
May 6, 1997
Review
70 days
Class
Class II
Product code
HQD
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K942365 (1994). 2 ancestors in all. 30 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor2004: 1 descendant cleared2003: 1 descendant cleared2016: 5 descendants cleared2006: 1 descendant cleared2021: 3 descendants cleared2018: 2 descendants cleared2017: 3 descendants cleared2019: 2 descendants cleared2022: 3 descendants cleared2024: 5 descendants cleared2026: 1 descendant cleared2023: 3 descendants clearedK942365 · Boston Vii · Polymer Technology Corp. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 5 descendants4 generations forward: 6 descendants5 generations forward: 11 descendants6 generations forward: 1 descendant K942365 · Boston Vii · Polymer Technology Corp. · 19940+5
  1. Root · 1 generation backK942365 Boston ViiPolymer Technology Corp. · 1994
  2. This deviceK970698 Boston ES Multivision (Enflufocon a) Contact LensPolymer Technology Corp. · 1997
  3. Descendant · cites it directly · 28 of its ownK033594 Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 2004 · Recalled
  4. Descendant · 2 generations on · 20 of its ownK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
  5. Descendant · 3 generations on · 19 of its ownK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
  6. Descendant · 4 generations on · 14 of its ownK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
  7. Descendant · 5 generations on · 9 of its ownK180616 OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens…Contamac, Ltd. · 2018

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2003: 12004: 12006: 12016: 52017: 32018: 22019: 22021: 32022: 32023: 32024: 52026: 1
2003high 5 (2016) · low 0 (2005)2026

Most influential descendants

Showing 5 of 30 · See all
  • K033594Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 2004 · cites it directly28descendants
  • K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016 · 2 generations on20descendants
  • K161461BostonSight PD Prosthetic DeviceBostonsight · 2016 · 3 generations on19descendants
  • K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017 · 4 generations on14descendants
  • K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A)…Contamac, Ltd. · 2018 · 5 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K942365Boston ViiPolymer Technology Corp.1994—
0 (this device)K970698Boston ES Multivision (Enflufocon a) Contact LensPolymer Technology Corp.1997—
+1K033594Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd.20042
+2K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight2016—
+3K161461BostonSight PD Prosthetic DeviceBostonsight20161
+4K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated2017—
+5K180616OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100…Contamac, Ltd.2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200610
201650
201730
201820
201920
202130
202230
202330
202450
202610
FIG. 1 — Lineage of K970698, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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
*K943177Boston (R) 7 - 30(Enflufocon a)
Summary page 2
…is made of the same material as BOSTON ES (enflufocon A), a daily wear fluoro silicone acrylate contact lens material as cleared under 510(k) Premarket Notification No. K943177. The United States Adopted Name (USAN) enflufocon A is unchanged. Substantial equivalence is also determined by the design equiva…
Polymer Technology Corp.19941
*K942365Boston Vii
Summary page 2
…ifocal Contact Lens as approved under PMA N16-895; and the BOSTON ENVISION aspheric single vision, back surface design as cleared under 510(k) Premarket Notification No. K942365. Equivalence in design is determined by both lens designs being aspheric, in which a series of different radius curves from cente…
Polymer Technology Corp.1994—
*—BAUSCH & LOMB Occasions™ (polymacon) Visibility Tinted Multifocal Contact Lens
Named without a submission number
—

Also cleared against K943177: 5 other devices →

What descends from it? (30)

See all 30

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033594Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd.200428
K032256Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a, Paflufocon B) Rigid Gas…No 7 Contact Lens Laboratory, Ltd.20030

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K033594 (Contamac, Ltd., 2004) has gone furthest, with 28 descendants of its own.
  • 5 other devices also cite its predicate K943177.

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.

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 BOSTON® MULTIVISION (enflufocon A) Contact Lens is indicated for daily wear for the correction of visual acuity in hyperopic and myopic, not-aphakic and aphakic, presbyopic patients with non-diseased eyes, who exhibit astigmatism of 2.00 diopters or less and can obtain satisfactory visual acuity. The lens provides a nominal functional add of 1.50 diopters. The lens may be disinfected using a chemical disinfecting system only.

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 K943177

5 other devices cite the same predicate.

  • K171575ENFLU 18 (enflufocon A) Daily Wear Contact LensContamac, Ltd. · 2017
  • K163254Acuity 18 (enflufocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc. · 2017
  • K020006Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
  • K000795Rigid Gas Permeable Contact LensPolymer Technology · 2000
  • K980741Boston EO Rigid Gas Permeable Contact Lens Material (Enflofocon B)Polymer Technology Div. Wilmington Partners, L.P. · 1998

More from Polymer Technology Corp.

120 FDA decisions under this applicant name. See the company

  • K011945Rigid Gas Permeable Contact Lens SolutionPolymer Technology Corp. · 2001
  • K980133Bausch & Lomb Wetting and Soaking SolutionPolymer Technology Corp. · 1998
  • K974466Boston Advance CleanerPolymer Technology Corp. · 1998
  • K973217Boston Liquid Enzymatic CleanerPolymer Technology Corp. · 1997
  • K951552Boston Contact Lens CasePolymer Technology Corp. · 1995

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/K970698 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970698: Boston ES Multivision (Enflufocon a) 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/K970698

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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