510(k) Report

510(k) · Cleared

Cleared

Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a, Paflufocon B) Rigid Gas Permeable (RGP) Daily Wear Contact LE

K032256510(k) TraditionalCleared Aug 29, 200338-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

No 7 Contact Lens Laboratory, Ltd. · LPL Lenses, Soft Contact, Daily Wear

Cleared on Aug 29, 2003 as substantially equivalent to K970698 (Polymer Technology Corp., 1997) and 3 other predicates after a 38-day review. Its family tree reaches back 2 generations to 1994.

Decided
Aug 29, 2003
Review
38 days
Class
Class II
Product code
LPL
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K942365 (1994). 6 ancestors in all, the oldest P870024 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor2000: 1 other ancestor1987: 1 other ancestor1994: 1 other ancestorK942365 · Boston Vii · Polymer Technology Corp. · 1994K970698 · Boston ES Multivision (Enflufocon a) Contact Lens · Polymer Technology Corp. · 199719851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K970698 · Boston ES Multivision (Enflufocon a) Contact Lens · Polymer Technology Corp. · 1997K942365 · Boston Vii · Polymer Technology Corp. · 19940
  1. Root · 2 generations backK942365 Boston ViiPolymer Technology Corp. · 1994
  2. 1 generation backK970698 Boston ES Multivision (Enflufocon a) Contact LensPolymer Technology Corp. · 1997
  3. This deviceK032256 Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a…No 7 Contact Lens Laboratory, Ltd. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K942365Boston ViiPolymer Technology Corp.1994—
−1K970698Boston ES Multivision (Enflufocon a) Contact LensPolymer Technology Corp.1997—
0 (this device)K032256Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a, Paflufocon B) Rigid…No 7 Contact Lens Laboratory, Ltd.2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199410
200010
200210
FIG. 1 — Lineage of K032256, 1994–2003Source: 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? (4)

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
*K970698Boston ES Multivision (Enflufocon a) Contact Lens
Summary page 2
…: Device name: Polymer Technology Boston Multifocal, Daily Wear 1400 North Goodman Street 5 10(k) #: K970698 Rochester, NY 14603 Polymer Technology Boston XO, Daily Wear 1400 North Goodman Stree…
Polymer Technology Corp.1997—
*K000795Rigid Gas Permeable Contact LensPolymer Technology2000—
*K021977Hybrid FS & Hybrid FS Toric (Hycofocon a) RGP Contact Lens for Daily WearContamac, Ltd.2002—
*P870024Fluoroperm RGP Contact Lenses
Summary page 2
…den Essex CBll 4JX UK Paragon Vision Sciences Fluoroperm 60/HDS, Flexible Wear 947 East Impala PMA#: P870024 Mesa, AZ 85204 Device Description: The QUASAR@ - QUASAR PLUS@ - QUASAR TORIC@ Contact Lenses are fabricated from the hy…
CooperVision, Inc.1987—

Also cleared against K970698: 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 9 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • 1 other device also cites its predicate K970698.

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—

What is it indicated for?

The QUASAR@(hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only. The QUASAR TORIC@(hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of…

Read the full statement (173 words)

The QUASAR@(hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.

The QUASAR TORIC@(hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia andor possesses retiactive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only.

The QUASAR PLUS@(hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia andor possesses rehctive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only.

Indications for use as stated in the FDA summary.

Also cleared against K970698

1 other device cites the same predicate.

  • K033594Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 20042 recalls

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/K032256 · printed Nov 3, 2026

Cite this page

510(k) Report. “K032256: Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a, Paflufocon B) Rigid Gas Permeable (RGP) Daily Wear Contact LE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032256

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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