510(k) · Cleared
ClearedVueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vuesonic, LLC · LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Cleared on Apr 1, 2021 as substantially equivalent to K974724 (Lens Comfort, Inc., 1998) and 1 other predicate after a 57-day review. Its family tree reaches back 5 generations to 1985.
- Decided
- Apr 1, 2021
- Review
- 57 days
- Class
- Class II
- Product code
- LYL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to P840068 (1985). 12 ancestors in all, the oldest K852386 (1985). No later device cites it as a predicate yet.
- Root · 5 generations backP840068 Delta Pacemaker Sys; Vigor DDD Model 950Boston Scientific · 1985
- 4 generations backK962112 New Comfort Contact Lens Care AccessoryLens Comfort, Inc. · 1996
- 3 generations backK974724 Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic…Lens Comfort, Inc. · 1998
- 2 generations backK982115 Lenserver Automatic Contact Lens Cleaning AccessoryRim-Wide Companies, Inc. · 1999
- 1 generation backK021699 Autolens Cleaning and Disinfecting UnitAutolens, Inc. · 2002
- This deviceK210300 VueSonic One Contact Lens Cleaning System, VueSonic Advance 2…Vuesonic, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | P840068 | Delta Pacemaker Sys; Vigor DDD Model 950 | Boston Scientific | 1985 | — |
| −4 | K962112 | New Comfort Contact Lens Care Accessory | Lens Comfort, Inc. | 1996 | — |
| −3 | K974724 | Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact… | Lens Comfort, Inc. | 1998 | — |
| −2 | K982115 | Lenserver Automatic Contact Lens Cleaning Accessory | Rim-Wide Companies, Inc. | 1999 | — |
| −1 | K021699 | Autolens Cleaning and Disinfecting Unit | Autolens, Inc. | 2002 | — |
| 0 (this device) | K210300 | VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens… | Vuesonic, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 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
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 |
|---|---|---|---|
| * | K974724 | Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact Lens Cleaner…Summary page 4…R 886.5928/21 CFR 886.5918 Regulatory Class: Class II Product Code: LYL/MRC Predicate Device(s): New Comfort Contact Lens Accessory (K974724) and AUTOLENS® System (K021699) Device Description: The VueSonic One Contact Lens Cleaning System and VueSonic Advance… | 1998 |
| * | K021699 | Autolens Cleaning and Disinfecting UnitSummary page 4…Regulatory Class: Class II Product Code: LYL/MRC Predicate Device(s): New Comfort Contact Lens Accessory (K974724) and AUTOLENS® System (K021699) Device Description: The VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning System… | 2002 |
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 36 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- None of the 10 ancestors has a recall.
- 2 other devices also cite its predicate K974724.
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. 2021, this device’s year, is highlighted.
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 VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.
The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210300: VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210300
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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