510(k) · Cleared
ClearedSoftmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact Lens Cleaner, Visonic Dome, Lensonic Contact
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lens Comfort, Inc. · LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Cleared on Mar 2, 1998 as substantially equivalent to K852386 (Barnes-Hind, Inc., 1985) and 6 other predicates after a 74-day review. Its family tree reaches back 2 generations to 1985. 4 later devices descend from it.
- Decided
- Mar 2, 1998
- Review
- 74 days
- Class
- Class II
- Product code
- LYL
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to P840068 (1985). 8 ancestors in all, the oldest K852386 (1985). 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backP840068 Delta Pacemaker Sys; Vigor DDD Model 950Boston Scientific · 1985
- 1 generation backK962112 New Comfort Contact Lens Care AccessoryLens Comfort, Inc. · 1996
- This deviceK974724 Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic…Lens Comfort, Inc. · 1998
- Descendant · cites it directly · 3 of its ownK982115 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 · 2 generations on · 0 of its ownK211361 3N Contact Lenses Adjunct CleanerSuzhou 3N Biological Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK210300 VueSonic One Contact Lens Cleaning System, VueSonic Advance 2…Vuesonic, LLC · 2021
Most influential descendants
Showing 4 of 4 · See all- K982115Lenserver Automatic Contact Lens Cleaning AccessoryRim-Wide Companies, Inc. · 1999 · cites it directly3descendants
- K021699Autolens Cleaning and Disinfecting UnitAutolens, Inc. · 2002 · cites it directly1descendant
- K2113613N Contact Lenses Adjunct CleanerSuzhou 3N Biological Technology Co., Ltd. · 2022 · 2 generations on0descendants
- K210300VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning SystemVuesonic, LLC · 2021 · cites it directly0descendants
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) | K974724 | Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact… | Lens Comfort, Inc. | 1998 | — |
| +1 | K982115 | Lenserver Automatic Contact Lens Cleaning Accessory | Rim-Wide Companies, Inc. | 1999 | — |
| +1 | K021699 | Autolens Cleaning and Disinfecting Unit | Autolens, Inc. | 2002 | — |
| +2 | K211361 | 3N Contact Lenses Adjunct Cleaner | Suzhou 3N Biological Technology Co., Ltd. | 2022 | — |
| +1 | 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 |
|---|---|---|
| 1999 | 1 | 0 |
| 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…ontact Lens Care Accessory Trade or Proprietary Name: New Comfort Contact Lens Care Accessory [807.92(a){3)] Equivalence: The Sola/Barnes-Hind® Hydra-Mat® (PMA Nos. P 810017 and P 840066); the Sola/Barnes-Hind® Soft Mate® Automatic Cleaning Unit (K 852386); the Clensatron® 700 CL (K 884414); the Visoni… | |
| * | 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…are Accessory Trade or Proprietary Name: New Comfort Contact Lens Care Accessory [807.92(a){3)] Equivalence: The Sola/Barnes-Hind® Hydra-Mat® (PMA Nos. P 810017 and P 840066); the Sola/Barnes-Hind® Soft Mate® Automatic Cleaning Unit (K 852386); the Clensatron® 700 CL (K 884414); the Visonic Dome™ (K 90… | |
| * | K852386 | Soft Mate Automatic Contact Lens Cleaning UnitSummary page 1…Care Accessory [807.92(a){3)] Equivalence: The Sola/Barnes-Hind® Hydra-Mat® (PMA Nos. P 810017 and P 840066); the Sola/Barnes-Hind® Soft Mate® Automatic Cleaning Unit (K 852386); the Clensatron® 700 CL (K 884414); the Visonic Dome™ (K 902306); the Lensonic (K 921615); and Lens Comfort Contact Lens Care Ac… | 1985 |
| * | K884414 | Clensatron Automatic Contact Lens CleanerSummary page 1…ivalence: The Sola/Barnes-Hind® Hydra-Mat® (PMA Nos. P 810017 and P 840066); the Sola/Barnes-Hind® Soft Mate® Automatic Cleaning Unit (K 852386); the Clensatron® 700 CL (K 884414); the Visonic Dome™ (K 902306); the Lensonic (K 921615); and Lens Comfort Contact Lens Care Accessory (K 962112) all have been g… | 1988 |
| * | K902306 | The Visonic Dome (TM)Summary page 1…® Hydra-Mat® (PMA Nos. P 810017 and P 840066); the Sola/Barnes-Hind® Soft Mate® Automatic Cleaning Unit (K 852386); the Clensatron® 700 CL (K 884414); the Visonic Dome™ (K 902306); the Lensonic (K 921615); and Lens Comfort Contact Lens Care Accessory (K 962112) all have been given market clearance to be us… | 1990 |
| * | K921615 | Lensonic (TM) Contact Lens Care AccessorySummary page 1…810017 and P 840066); the Sola/Barnes-Hind® Soft Mate® Automatic Cleaning Unit (K 852386); the Clensatron® 700 CL (K 884414); the Visonic Dome™ (K 902306); the Lensonic (K 921615); and Lens Comfort Contact Lens Care Accessory (K 962112) all have been given market clearance to be used as an accessory for co… | 1992 |
| * | K962112 | New Comfort Contact Lens Care AccessorySummary page 1…omatic Cleaning Unit (K 852386); the Clensatron® 700 CL (K 884414); the Visonic Dome™ (K 902306); the Lensonic (K 921615); and Lens Comfort Contact Lens Care Accessory (K 962112) all have been given market clearance to be used as an accessory for contact lens care. [807.92(a)(4)]} Device ription: The New… | 1996 |
What descends from it? (4)
3 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 13 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K982115 (Rim-Wide Companies, Inc., 1999) has gone furthest, with 3 descendants 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 New Comfort Contact Lens Care Accessory is intended for use in conjunction with contact lens solutions as an accessory in the cleaning of contact lenses. The New Comfort Contact Lens Care Accessory is indicated as aid for cleaning as an accessory for soft hydrophilic lenses and gas permeable lenses when used with the appropriate Allergan® Soft Mate® solutions such as the Consept® Cleaning and Disinfection System which is comprised of the Allergan®…
Read the full statement (137 words)
The New Comfort Contact Lens Care Accessory is intended for use in conjunction with contact lens solutions as an accessory in the cleaning of contact lenses.
The New Comfort Contact Lens Care Accessory is indicated as aid for cleaning as an accessory for soft hydrophilic lenses and gas permeable lenses when used with the appropriate Allergan® Soft Mate® solutions such as the Consept® Cleaning and Disinfection System which is comprised of the Allergan® Soft Mate® Consept®-1 Cleaning and Disinfecting solution and Allergan® Soft Mate® Consept®-2 Neutralizing and Rinsing Solution or Spray. The New Comfort Contact Lens Care Accessory is indicated for use for gas permeable solutions such as Allergan® Gas Permeable Daily Cleaner and Allergan® ComfortCare GP Wetting and Soaking Solution. The New Comfort Contact Lens Care Accessory may be used for a receptacle for chemical disinfection.
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/K974724 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974724: Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact Lens Cleaner, Visonic Dome, Lensonic Contact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974724
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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