510(k) · Cleared
ClearedLenserver Automatic Contact Lens Cleaning Accessory
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rim-Wide Companies, Inc. · LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Cleared on Jan 13, 1999 as substantially equivalent to K852386 (Barnes-Hind, Inc., 1985) and 6 other predicates after a 211-day review. Its family tree reaches back 3 generations to 1985. 3 later devices descend from it.
- Decided
- Jan 13, 1999
- Review
- 211 days
- Class
- Class II
- Product code
- LYL
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to P840068 (1985). 9 ancestors in all, the oldest K852386 (1985). 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backP840068 Delta Pacemaker Sys; Vigor DDD Model 950Boston Scientific · 1985
- 2 generations backK962112 New Comfort Contact Lens Care AccessoryLens Comfort, Inc. · 1996
- 1 generation backK974724 Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic…Lens Comfort, Inc. · 1998
- This deviceK982115 Lenserver Automatic Contact Lens Cleaning AccessoryRim-Wide Companies, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK021699 Autolens Cleaning and Disinfecting UnitAutolens, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK211361 3N Contact Lenses Adjunct CleanerSuzhou 3N Biological Technology Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK210300 VueSonic One Contact Lens Cleaning System, VueSonic Advance 2…Vuesonic, LLC · 2021
Most influential descendants
Showing 3 of 3 · See all- K021699Autolens Cleaning and Disinfecting UnitAutolens, Inc. · 2002 · cites it directly1descendant
- K2113613N Contact Lenses Adjunct CleanerSuzhou 3N Biological Technology Co., Ltd. · 2022 · cites it directly0descendants
- K210300VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning SystemVuesonic, LLC · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P840068 | Delta Pacemaker Sys; Vigor DDD Model 950 | Boston Scientific | 1985 | — |
| −2 | K962112 | New Comfort Contact Lens Care Accessory | Lens Comfort, Inc. | 1996 | — |
| −1 | K974724 | Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact… | Lens Comfort, Inc. | 1998 | — |
| 0 (this device) | K982115 | Lenserver Automatic Contact Lens Cleaning Accessory | Rim-Wide Companies, Inc. | 1999 | — |
| +1 | K021699 | Autolens Cleaning and Disinfecting Unit | Autolens, Inc. | 2002 | — |
| +1 | K211361 | 3N Contact Lenses Adjunct Cleaner | Suzhou 3N Biological Technology Co., Ltd. | 2022 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (7)
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 |
|---|---|---|---|
| * | P810017 | Soft Mate Weekly Cleaning Solution FDA lists this PMA only through its supplements; the earliest we hold is P810017/S001 (Mar 25, 1982). Summary page 1….D. LENSERVER Automatic LENSERVER Automatic Contact Lens Cleaning Accessory Contact Lens Cleaning Accessory Unclassified Sola/Barnes-Hind Hydra-Mat Barnes-Hind, Inc. P810017, P840066 Sola/Barnes-Hind Soft Mate Barnes-Hind, Inc. K852386 SOFT MATE Automatic Contact Lens Cleaning Unit Clensatron 700 C… | |
| * | P840066 | Soft Mate (R) Hydrogen Peroxide Disinfection System FDA lists this PMA only through its supplements; the earliest we hold is P840066/S002 (Dec 1, 1986). Summary page 1…ERVER Automatic LENSERVER Automatic Contact Lens Cleaning Accessory Contact Lens Cleaning Accessory Unclassified Sola/Barnes-Hind Hydra-Mat Barnes-Hind, Inc. P810017, P840066 Sola/Barnes-Hind Soft Mate Barnes-Hind, Inc. K852386 SOFT MATE Automatic Contact Lens Cleaning Unit Clensatron 700 CL Queste… | |
| * | K852386 | Soft Mate Automatic Contact Lens Cleaning UnitSummary page 1…ing Accessory Contact Lens Cleaning Accessory Unclassified Sola/Barnes-Hind Hydra-Mat Barnes-Hind, Inc. P810017, P840066 Sola/Barnes-Hind Soft Mate Barnes-Hind, Inc. K852386 SOFT MATE Automatic Contact Lens Cleaning Unit Clensatron 700 CL Questech International, Inc. K884414 CLENSATRON Automatic C… | 1985 |
| * | K884414 | Clensatron Automatic Contact Lens CleanerSummary page 1…P810017, P840066 Sola/Barnes-Hind Soft Mate Barnes-Hind, Inc. K852386 SOFT MATE Automatic Contact Lens Cleaning Unit Clensatron 700 CL Questech International, Inc. K884414 CLENSATRON Automatic Contact Lens Cleaner Visonic Dome Vista Vision, Inc. K902306 VISONIC DOME Contact Lens Cleaning Accesso… | 1988 |
| * | K902306 | The Visonic Dome (TM)Summary page 1…omatic Contact Lens Cleaning Unit Clensatron 700 CL Questech International, Inc. K884414 CLENSATRON Automatic Contact Lens Cleaner Visonic Dome Vista Vision, Inc. K902306 VISONIC DOME Contact Lens Cleaning Accessory Lensonic Manufacturer: 510(k) number/clearance information: Pred… | 1990 |
| * | K921615 | Lensonic (TM) Contact Lens Care AccessorySummary page 2…edicate device labeling: 6. Predicate device name: Manufacturer: 510(k) number/clearance information: Predicate device labeling: Personal Professional Products, Inc. K921615 Lensonic Contact Lens Care Accessory Lens Comfort Lens Comfort, Inc. K921615 Lens Comfort Ultrasonic Contact Lens Care Access… | 1992 |
| * | K974724 | Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact Lens Cleaner…Summary page 2…K921615 Lens Comfort Ultrasonic Contact Lens Care Accessory 7. Predicate device name: New Comfort Manufacturer: Lens Comfort, Inc. 510(k) number/clearance information: K974724 Predicate device labeling: New Comfort Contact Lens Care Accessory Description of device and reason for submission The LENSERVER… | 1998 |
What descends from it? (3)
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 14 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K021699 (Autolens, Inc., 2002) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate P810017.
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 LENSERVER Automatic Contact Lens Cleaning Accessory is intended for use as an adjunct in cleaning both soft hydrophilic and rigid gas permeable contact lenses using approved contact lens cleaning solutions. Examples of approved cleaning solutions indicated for use with the LENSERVER Automatic for soft hydrophilic lenses are the Allergan Soft Mate Consept-1 Cleaning and Disinfecting Solution, Allsrgan Soft Mate Conséept-2 Neutralizing and Rinsing…
Read the full statement (99 words)
The LENSERVER Automatic Contact Lens Cleaning Accessory is intended for use as an adjunct in cleaning both soft hydrophilic and rigid gas permeable contact lenses using approved contact lens cleaning solutions.
Examples of approved cleaning solutions indicated for use with the LENSERVER Automatic for soft hydrophilic lenses are the Allergan Soft Mate Consept-1 Cleaning and Disinfecting Solution, Allsrgan Soft Mate Conséept-2 Neutralizing and Rinsing Solution, or Spray. “The LENSERVER Automatic is indicated for cleaning rigid gas permeable lenses in conjunction with approved solutions such as Allergan Gas Permeable Daily Cleaner and Allergan ComfortCare Gas Permeable Wetting and Soaking Solution.
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/K982115 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982115: Lenserver Automatic Contact Lens Cleaning Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982115
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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