510(k) · Cleared
ClearedSauflon 55 UV Soft (Hydrophilic) Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sauflon Pharmaceuticals, Ltd. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Dec 26, 2001 as substantially equivalent to K973063 (Aspect Vision Care, Ltd., 1997) after a 51-day review. Its family tree reaches back 3 generations to 1995. 7 later devices descend from it.
- Decided
- Dec 26, 2001
- Review
- 51 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K951893 (1995). 4 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK951893 Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle…Permeable Technologies, Inc. · 1995
- 2 generations backK971164 Frequency 55 (Methafilcon a) Hydrophilic Contact LensAspect Vision Care, Ltd. · 1997
- 1 generation backK973063 Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily WearAspect Vision Care, Ltd. · 1997 · Recalled
- This deviceK013649 Sauflon 55 UV Soft (Hydrophilic) Contact LensSauflon Pharmaceuticals, Ltd. · 2001
- Descendant · cites it directly · 3 of its ownK020392 Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for…CooperVision, Inc. · 2002
- Descendant · 2 generations on · 2 of its ownK182247 ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses…Vizionfocus, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK133735 Eye Secret 55 UV Aspheric (Methafilcon a) Soft (Hydrophilic) Contact…Yung Sheng Optical Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK243953 Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens…Vizionfocus, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK192225 Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily…Vizionfocus, Inc. · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K020392Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily WearCooperVision, Inc. · 2002 · cites it directly3descendants
- K182247ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)Vizionfocus, Inc. · 2018 · 2 generations on2descendants
- K133735Eye Secret 55 UV Aspheric (Methafilcon a) Soft (Hydrophilic) Contact LensYung Sheng Optical Co., Ltd. · 2014 · cites it directly1descendant
- K243953Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)Vizionfocus, Inc. · 2025 · 2 generations on0descendants
- K192225Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact LensesVizionfocus, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951893 | Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle Frequency 55… | Permeable Technologies, Inc. | 1995 | — |
| −2 | K971164 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens | Aspect Vision Care, Ltd. | 1997 | — |
| −1 | K973063 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear | Aspect Vision Care, Ltd. | 1997 | 1 |
| 0 (this device) | K013649 | Sauflon 55 UV Soft (Hydrophilic) Contact Lens | Sauflon Pharmaceuticals, Ltd. | 2001 | — |
| +1 | K020392 | Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily Wear | CooperVision, Inc. | 2002 | — |
| +2 | K182247 | ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted… | Vizionfocus, Inc. | 2018 | — |
| +1 | K133735 | Eye Secret 55 UV Aspheric (Methafilcon a) Soft (Hydrophilic) Contact Lens | Yung Sheng Optical Co., Ltd. | 2014 | — |
| +2 | K243953 | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | Vizionfocus, Inc. | 2025 | — |
| +3 | K192225 | Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact… | Vizionfocus, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
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 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K973063 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily WearSummary page 1…Wear are substantially equivalent to FREQUENCY 55 (methafilcon A) Hydrophilic Contact lenses for Daily Wear (clear and tinted) that received market clearance pursuant to K973063, currently marketed in the USA. DESCRIPTION of the DEVICE: The SAUFLON 55UV (methafilcon A) Soft (Hydrophilic) Visibility Tint… | 1997 |
| † | K971164 | Frequency 55 (Methafilcon a) Hydrophilic Contact Lens | 1997 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K020392 (CooperVision, Inc., 2002) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K973063.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
The Sauflon 55 UV soft (hydrophilic) contact lens is indicated for daily wear for the correction of the
refractive ametropia (myopia and hyperopia) and
astigmatism in aphakic and not-aphakic persons with
non-diseased eyes that may exhibit astigmatism up to
2.00 Dioptres that does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for daily
wear in a Frequent Replacement Program. The lenses
may be disinfected using chemical or hydrogen
peroxide disinfection systems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013649 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013649: Sauflon 55 UV Soft (Hydrophilic) 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/K013649
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026