510(k) · Cleared
ClearedOcu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ocu-Ease Optical Products, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Apr 26, 2002 as substantially equivalent to K992950 (Prosthetic Soft Lens Corp., 1999) and 1 other predicate after a 53-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Apr 26, 2002
- Review
- 53 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K961103 (1996). 12 ancestors in all, the oldest K950283 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK961103 Benz 38 Clear & with Blue Visibility TintBenz Research and Development Corp. · 1996
- 3 generations backK980554 Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear…Alden Optical Labs., Inc. · 1998
- 2 generations backK983278 Oxylens Tinted, Prosthetic (Hioxifilcon B) Tinted, Soft Daily Wear…Alden Optical Labs., Inc. · 1998
- 1 generation backK992950 Custom Prosthetic (Hefilcon a) Soft LensProsthetic Soft Lens Corp. · 1999
- This deviceK020690 Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft Contact LensOcu-Ease Optical Products, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K961103 | Benz 38 Clear & with Blue Visibility Tint | Benz Research and Development Corp. | 1996 | — |
| −3 | K980554 | Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact… | Alden Optical Labs., Inc. | 1998 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K992950 | Custom Prosthetic (Hefilcon a) Soft LensSummary page 2…cate Device: (substantially equivalent to indication use) 1. Custom Prosthetic Soft Lens (hefilcon A) Manufactured by Prosthetic Soft Lens Corp. Englewood, CO. 510(k) #K992950 2. Ocu-Flex-53 (ocufilcon B) Soft Contact Lens Ocu-Ease Optical Prod. Pinole, CA. PMA#P820051 Device Description: The dimensio… | 1999 |
| * | P820051 | Ocu-Flex FDA lists this PMA only through its supplements; the earliest we hold is P820051/S002 (Feb 20, 1986). Summary page 2…lcon A) Manufactured by Prosthetic Soft Lens Corp. Englewood, CO. 510(k) #K992950 2. Ocu-Flex-53 (ocufilcon B) Soft Contact Lens Ocu-Ease Optical Prod. Pinole, CA. PMA#P820051 Device Description: The dimensions of the Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lens are the same as approve… |
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 6 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 1 other device also cites its predicate K992950.
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 Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lenses are 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 lens for cosmetic management of conditions such as corneal, iris 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…
Read the full statement (108 words)
The Ocu-Flex-53 Custom Prosthetic (ocufilcon B) Soft Contact Lenses are 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 lens for cosmetic management of conditions such as corneal, iris 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 not-aphakic persons or for occlusive therapy conditions such as diplopia, amblyopia or extreme photophobia.
The lens may be disinfected with a chemical (not heat) 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/K020690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020690: Ocu-Flex-53 Custom Prosthetic (Ocufilcon B) Soft 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/K020690
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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