510(k) · Cleared
ClearedSamfilcon B Custom Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch + Lomb, Incorporated · LPL Lenses, Soft Contact, Daily Wear
Cleared on Nov 17, 2023 as substantially equivalent to K131208 (Bausch & Lomb, Inc., 2013) and 1 other predicate after a 227-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Nov 17, 2023
- Review
- 227 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K960926 (1996). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK960926 Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact LensUnilens Corp., USA · 1996
- 3 generations backK020927 Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted…Bausch & Lomb · 2002
- 2 generations backK050948 Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact LensBausch & Lomb, Inc. · 2005
- 1 generation backK131208 Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb…Bausch & Lomb, Inc. · 2013
- This deviceK230954 Samfilcon B Custom Contact LensBausch + Lomb, Incorporated · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K960926 | Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens | Unilens Corp., USA | 1996 | — |
| −3 | K020927 | Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens | Bausch & Lomb | 2002 | — |
| −2 | K050948 | Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact Lens | Bausch & Lomb, Inc. | 2005 | — |
| −1 | K131208 | Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort… | Bausch & Lomb, Inc. | 2013 | — |
| 0 (this device) | K230954 | Samfilcon B Custom Contact Lens | Bausch + Lomb, Incorporated | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | K131208 | Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon…Summary page 5…thalmic Medical Device Device Classification: Class II (21 CFR 886.5925) Product Code: LPL Predicate Device: Bausch + Lomb Ultra (samfilcon A) Contact Lens, K131208 for the material, and Alden HP 54 Sphere, Toric, Multifocal and Toric Multifocal Soft Contact Lenses, K091327 for the Indication… | 2013 |
| * | K091327 | Alden HP 54 Sphee 7 Hip 54 Toric Contact Lenses, Alden HP 54 Multifocal &HP 54 Toric…Summary page 5…e Device: Bausch + Lomb Ultra (samfilcon A) Contact Lens, K131208 for the material, and Alden HP 54 Sphere, Toric, Multifocal and Toric Multifocal Soft Contact Lenses, K091327 for the Indications for Use. Device Description: The Bausch + Lomb Samfilcon B Contact Lens is made from a silicone hydrogel ma… | 2010 |
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 27 years and passes through 4 companies; a new generation was cleared every 8.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 5 other devices also cite its predicate K131208.
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. 2023, this device’s year, is highlighted.
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?
Bausch + Lomb Samfilcon B Contact Lens for daily wear is indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. Bausch + Lomb Samfilcon B Contact Lens for Astigmatism for daily wear is indicated for the correction of…
Read the full statement (258 words)
Bausch + Lomb Samfilcon B Contact Lens for daily wear is indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
Bausch + Lomb Samfilcon B Contact Lens for Astigmatism for daily wear is indicated for the correction of refractive ametropia (myopia, hyperopia and/or astigmatism) in aphakic and not aphakic persons with non-diseased eyes with refractive astigmatism not exceeding 10.00 diopters.
Bausch + Lomb Samfilcon B Contact Lens for Presbyopia for daily wear is indicated for the correction of refractive ametropia (myopia or hyperopia) and presbyopia in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
Bausch + Lomb Samfilcon B Contact Lens Multifocal for Astigmatism for daily wear is indicated for the correction of refractive ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia in aphakic and not aphakic persons with non-diseased eyes with refractive astigmatism not exceeding 10.00 diopters.
When prescribed for frequent planned replacement wear, the contact lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
The Samfilcon B Contact Lens is available for a frequent/planned replacement modality.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230954 · printed Nov 4, 2026
Cite this page
510(k) Report. “K230954: Samfilcon B Custom Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K230954
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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