510(k) · Cleared
ClearedPurilens System for Cleaning and Disinfecting Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Purilens, Inc. · LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Cleared on Oct 1, 1999 as substantially equivalent to P860023/
- Decided
- Oct 1, 1999
- Review
- 113 days
- Class
- Class II
- Product code
- LYL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to P840068 (1985). 7 ancestors in all, the oldest K852386 (1985). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P840068 | Delta Pacemaker Sys; Vigor DDD Model 950 | Boston Scientific | 1985 | — |
| −1 | K962112 | New Comfort Contact Lens Care Accessory | Lens Comfort, Inc. | 1996 | — |
| 0 (this device) | K991965 | Purilens System for Cleaning and Disinfecting Contact Lenses | Purilens, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 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 LYL? 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 LYL device
- #1 K211361 3N Contact Lenses Adjunct Cleanerscore 3.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | P860023/ | Bausch & Lomb (R) Renu (R) Multi-Purpose Solution A supplement to the PMA, as the summary prints it. | 1994 |
| * | K962112 | New Comfort Contact Lens Care AccessorySummary page 2…s substantially equivalent to contact lens ultrasonic cleaners and hand-driven mechanical agitation units (The Lens Comfort, Inc. Ultrasonic Contact Lens Care Accessory, K962112, cleared November 29, 1996; the Sola/Barnes -Hind Soft Mate Automatic Cleaning Unit, K852386, cleared 9/4/85; and the Clensatron… | 1996 |
| * | K852386 | Soft Mate Automatic Contact Lens Cleaning UnitSummary page 2…tation units (The Lens Comfort, Inc. Ultrasonic Contact Lens Care Accessory, K962112, cleared November 29, 1996; the Sola/Barnes -Hind Soft Mate Automatic Cleaning Unit, K852386, cleared 9/4/85; and the Clensatron 700CL, K884414 cleared 12/29/88). The turbulence created by this action loosens lens deposits… | 1985 |
| * | K884414 | Clensatron Automatic Contact Lens CleanerSummary page 2…tact Lens Care Accessory, K962112, cleared November 29, 1996; the Sola/Barnes -Hind Soft Mate Automatic Cleaning Unit, K852386, cleared 9/4/85; and the Clensatron 700CL, K884414 cleared 12/29/88). The turbulence created by this action loosens lens deposits and microorganisms from the lens surfaces and plac… | 1988 |
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 14 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All LYL devicesLYL Accessories, Solution, Ultrasonic Cleaners For Lenses: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LYL
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LYL
Too few LYL 510(k)s in any year since 2007 to give a median.
Recalls per year · LYL
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LYL
4in 2025
MAUDE reports naming product code LYL, 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 | 0 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 0 | — | 8 | 9 |
| 2011 | 0 | — | 1 | 10 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 1 | 5 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 1 | 5 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Purilens® System is indicated for the cleaning and disinfection of soft (hydrophilic) contact lenses by means of subsonic agitation to remove lens deposits and microorganisms, and ultraviolet irradiation of the surrounding storage solution for disinfection. The lenses may be stored in the disinfected solution for a period of 24 hours following the cleaning and disinfection cycle.
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/K991965 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991965: Purilens System for Cleaning and Disinfecting Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991965
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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