510(k) · Cleared
ClearedOxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted an Non-Sighted Eyes)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alden Optical Labs., Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Nov 25, 1998 as substantially equivalent to K980554 (Alden Optical Labs., Inc., 1998) and 2 other predicates after a 69-day review. Its family tree reaches back 2 generations to 1996. 3 later devices descend from it.
- Decided
- Nov 25, 1998
- Review
- 69 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K961103 (1996). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK961103 Benz 38 Clear & with Blue Visibility TintBenz Research and Development Corp. · 1996
- 1 generation backK980554 Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear…Alden Optical Labs., Inc. · 1998
- This deviceK983278 Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear…Alden Optical Labs., Inc. · 1998
- Descendant · cites it directly · 2 of its ownK992950 Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp. · 1999
- Descendant · 2 generations on · 0 of its ownK041700 Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily…Cantor & Nissel, Ltd. · 2004
- Descendant · 2 generations on · 0 of its ownK020690 Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact LensOcu-Ease Optical Products, Inc. · 2002
Most influential descendants
Showing 3 of 3 · See all- K992950Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp. · 1999 · cites it directly2descendants
- K041700Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily WearCantor & Nissel, Ltd. · 2004 · 2 generations on0descendants
- K020690Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact LensOcu-Ease Optical Products, Inc. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961103 | Benz 38 Clear & with Blue Visibility Tint | Benz Research and Development Corp. | 1996 | — |
| −1 | K980554 | Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact… | Alden Optical Labs., Inc. | 1998 | — |
| 0 (this device) | K983278 | Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact… | Alden Optical Labs., Inc. | 1998 | — |
| +1 | K992950 | Custom Prosthetic (Hefilcon a) Soft Lens | Prosthetic Soft Lens Corp. | 1999 | — |
| +2 | K041700 | Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily Wear | Cantor & Nissel, Ltd. | 2004 | — |
| +2 | K020690 | Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact Lens | Ocu-Ease Optical Products, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980554 | Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens…Summary page 4…The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the devices is equivalent to the Alden - Classic Tinted (polymacon) 510(k) #K980554, the Oxylens (hioxifilcon B) 510(k) # K981252 and the Benz-G 3X (hioxifilcon B) 510(k) # K964528. Being similar with respect to m… | 1998 |
| * | K981252 | Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss (Clear & Blue…Summary page 4…toxicology and manufacturing/chemistry data) of the devices is equivalent to the Alden - Classic Tinted (polymacon) 510(k) #K980554, the Oxylens (hioxifilcon B) 510(k) # K981252 and the Benz-G 3X (hioxifilcon B) 510(k) # K964528. Being similar with respect to materials, physical construction and safety & e… | 1998 |
| * | K964528 | (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses…Summary page 4…devices is equivalent to the Alden - Classic Tinted (polymacon) 510(k) #K980554, the Oxylens (hioxifilcon B) 510(k) # K981252 and the Benz-G 3X (hioxifilcon B) 510(k) # K964528. Being similar with respect to materials, physical construction and safety & effectiveness to the predicate devices, this meets t… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992950 | Custom Prosthetic (Hefilcon a) Soft Lens | 1999 | 2 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K992950 (Prosthetic Soft Lens Corp., 1999) has gone furthest, with 2 descendants of its own.
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 OXYLENS PROSTHETIC (hioxifilcon B), Tinted Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not…
Read the full statement (241 words)
The OXYLENS PROSTHETIC (hioxifilcon B), Tinted Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with either a chemical or a heat disinfection system.
The OXYLENS TINTED (hioxifilcon B) Spherical Soft Contact Lenses for daily wear, are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. 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. The lens may be disinfected with either a chemical or a heat disinfection system.
The OXYLENS TINTED (hioxifilcon B) Toric Soft Contact Lenses for daily wear, are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected with either a chemical or a heat disinfection system.
The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.
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/K983278 · printed Nov 5, 2026
Cite this page
510(k) Report. “K983278: Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted an Non-Sighted Eyes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983278
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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