510(k) · Cleared
ClearedCustom Prosthetic (Hefilcon a) Soft Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prosthetic Soft Lens Corp. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Nov 18, 1999 as substantially equivalent to K984259 (Cl-Tinters, 1999) and 2 other predicates after a 78-day review. Its family tree reaches back 3 generations to 1996. 2 later devices descend from it.
- Decided
- Nov 18, 1999
- Review
- 78 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K961103 (1996). 10 ancestors in all, the oldest K950283 (1995). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK961103 Benz 38 Clear & with Blue Visibility TintBenz Research and Development Corp. · 1996
- 2 generations backK980554 Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear…Alden Optical Labs., Inc. · 1998
- 1 generation backK983278 Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear…Alden Optical Labs., Inc. · 1998
- This deviceK992950 Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp. · 1999
- Descendant · cites it directly · 0 of its ownK041700 Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily…Cantor & Nissel, Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK020690 Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact LensOcu-Ease Optical Products, Inc. · 2002
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K961103 | Benz 38 Clear & with Blue Visibility Tint | Benz Research and Development Corp. | 1996 | — |
| −2 | K980554 | Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact… | Alden Optical Labs., Inc. | 1998 | — |
| −1 | K983278 | Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact… | Alden Optical Labs., Inc. | 1998 | — |
| 0 (this device) | K992950 | Custom Prosthetic (Hefilcon a) Soft Lens | Prosthetic Soft Lens Corp. | 1999 | — |
| +1 | K041700 | Cantor & Nissel Hand Painted Prosthetic Soft Contact Lens for Daily Wear | Cantor & Nissel, Ltd. | 2004 | — |
| +1 | 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 |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K984259 | Prosthetic (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)Summary page 1…ns Classification Name: Lens, Soft Contact, Daily Wear Class and Number: Class I, LPL Substantially Equivalent to: (1) Prosthetic (polymacon) Hydrophilic Contact Lens, K984259 (2) Classic Prosthetic (polymacon), K983053 (3) Oxylens tinted Prosthetic (hioxifilcon B), K983278 Device Description: The Pros… | 1999 |
| * | K983053 | Alden Classic Prosthetic (Polymacon) Tinted, Soft Daily Wear Contact Lens (Sighted and…Summary page 1…Daily Wear Class and Number: Class I, LPL Substantially Equivalent to: (1) Prosthetic (polymacon) Hydrophilic Contact Lens, K984259 (2) Classic Prosthetic (polymacon), K983053 (3) Oxylens tinted Prosthetic (hioxifilcon B), K983278 Device Description: The Prosthetic (hefilcon A)Soft Lens is a partially… | 1998 |
| * | K983278 | Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear Contact Lens (Sighted…Summary page 1…y Equivalent to: (1) Prosthetic (polymacon) Hydrophilic Contact Lens, K984259 (2) Classic Prosthetic (polymacon), K983053 (3) Oxylens tinted Prosthetic (hioxifilcon B), K983278 Device Description: The Prosthetic (hefilcon A)Soft Lens is a partially or totally white opaque lens that is painted or printed… | 1998 |
What descends from it? (2)
2 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 3 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K041700 (Cantor & Nissel, Ltd., 2004) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K984259.
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 Prosthetic (hefilcon A) Soft Contact Lens is indicated for daily wear to enhance or alter the appearance of the eye, including ocular masking, in sighted or non-sighted eyes, that may require a prosthetic contact lens for the cosmetic management of corneal, iris, scleral or lens abnormalities; or for persons wishing to change the appearance of their eyes without eye abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia or astigmatism) in aphakic or non-aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with a chemical disinfection system.
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/K992950 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992950: Custom Prosthetic (Hefilcon a) Soft Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992950
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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