510(k) · Cleared

Cleared

New Comfort Contact Lens Care Accessory

K962112510(k) TraditionalCleared Nov 29, 1996182-day reviewClass II21 CFR 886.5928

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lens Comfort, Inc. · LYL Accessories, Solution, Ultrasonic Cleaners For Lenses

Cleared on Nov 29, 1996 as substantially equivalent to P840068 (Boston Scientific, 1985) and 3 other predicates after a 182-day review. Its family tree reaches back 1 generation to 1985. 6 later devices descend from it.

Decided: Nov 29, 1996
Review: 182 days
Class: Class II
Product code: LYL
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to P840068 (1985). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backP840068 Delta Pacemaker Sys; Vigor DDD Model 950Boston Scientific · 1985
This deviceK962112 New Comfort Contact Lens Care AccessoryLens Comfort, Inc. · 1996
Descendant · cites it directly · 4 of its ownK974724 Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic…Lens Comfort, Inc. · 1998
Descendant · 2 generations on · 3 of its ownK982115 Lenserver Automatic Contact Lens Cleaning AccessoryRim-Wide Companies, Inc. · 1999
Descendant · 2 generations on · 1 of its ownK021699 Autolens Cleaning and Disinfecting UnitAutolens, Inc. · 2002
Descendant · 3 generations on · 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

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1998high 2 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 6 · See all

K974724Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact Lens Cleaner…Lens Comfort, Inc. · 1998 · cites it directly4descendants
K982115Lenserver Automatic Contact Lens Cleaning AccessoryRim-Wide Companies, Inc. · 1999 · 2 generations on3descendants
K021699Autolens Cleaning and Disinfecting UnitAutolens, Inc. · 2002 · 2 generations on1descendant
K2113613N Contact Lenses Adjunct CleanerSuzhou 3N Biological Technology Co., Ltd. · 2022 · 3 generations on0descendants
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
−1	P840068	Delta Pacemaker Sys; Vigor DDD Model 950	Boston Scientific	1985	—
0 (this device)	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	—
+2	K982115	Lenserver Automatic Contact Lens Cleaning Accessory	Rim-Wide Companies, Inc.	1999	—
+2	K021699	Autolens Cleaning and Disinfecting Unit	Autolens, Inc.	2002	—
+3	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
1988	1	0
1990	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	2	0
2002	1	0
2021	1	0
2022	1	0

FIG. 1 — Lineage of K962112, 1985–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	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 …nic Contact Lens Care Accessory Liade.or Propristary Name; Lens Comfort Contact Lens Care Accessory (807.92(a)3)] Enulvsiance; The Sola/Barnes-Hind® Hydrs-Mat® (PMA Nos. P 810017 and P 840068); the Sola/Barnes-Hind® Soft Mate® Automstic Cleaning Unit (K 882388); tho Clonsatron® 700 CL (K 884414); the Vison…	Advanced Medical Optics, Inc.		—
*	P840068	Delta Pacemaker Sys; Vigor DDD Model 950 Summary page 1 …ns Care Accessory Liade.or Propristary Name; Lens Comfort Contact Lens Care Accessory (807.92(a)3)] Enulvsiance; The Sola/Barnes-Hind® Hydrs-Mat® (PMA Nos. P 810017 and P 840068); the Sola/Barnes-Hind® Soft Mate® Automstic Cleaning Unit (K 882388); tho Clonsatron® 700 CL (K 884414); the Visonic Dome™ (K 90…	Boston Scientific	1985	—
Kept off the family tree	K882388	FDA’s K882388 is MR. Razor II Twin Our OCR of the scanned summary read K882388, FDA’s number for MR. Razor II Twin (Burney Products Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Sola/Barnes-Hind® Soft Mate® Automatic Cleaning Unit”. Kept off the family tree. Summary page 1 …s Care Accessory (807.92(a)3)] Enulvsiance; The Sola/Barnes-Hind® Hydrs-Mat® (PMA Nos. P 810017 and P 840068); the Sola/Barnes-Hind® Soft Mate® Automstic Cleaning Unit (K 882388); tho Clonsatron® 700 CL (K 884414); the Visonic Dome™ (K 9023086); and the Lensonic (K 821815) all hava been given market clesr…	Burney Products Corp.	1988	—
*	K884414	Clensatron Automatic Contact Lens Cleaner Summary page 1 …vsiance; The Sola/Barnes-Hind® Hydrs-Mat® (PMA Nos. P 810017 and P 840068); the Sola/Barnes-Hind® Soft Mate® Automstic Cleaning Unit (K 882388); tho Clonsatron® 700 CL (K 884414); the Visonic Dome™ (K 9023086); and the Lensonic (K 821815) all hava been given market clesrance to be used as an accessory fur…	Questech Intl., Inc.	1988	—
*	K902306	The Visonic Dome (TM)	Vista Vision	1990	—
Kept off the family tree	K821815	FDA’s K821815 is Advance C-Reactive Protein (CRP) Assay Our OCR of the scanned summary read K821815, FDA’s number for Advance C-Reactive Protein (CRP) Assay (Syva Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Lensonic”. Kept off the family tree. Summary page 1 …and P 840068); the Sola/Barnes-Hind® Soft Mate® Automstic Cleaning Unit (K 882388); tho Clonsatron® 700 CL (K 884414); the Visonic Dome™ (K 9023086); and the Lensonic (K 821815) all hava been given market clesrance to be used as an accessory fur contact lens oare. (807.92(s)(4)) Davice Deacrintign: The…	Syva Co.	1982	—

Also cleared against P810017: 2 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K974724	Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact Lens Cleaner…	Lens Comfort, Inc.	1998	4
K991965	Purilens System for Cleaning and Disinfecting Contact Lenses	Purilens, Inc.	1999	0

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?

None of the 3 ancestors has a recall.
Of its descendants, K974724 (Lens Comfort, Inc., 1998) has gone furthest, with 4 descendants of its own.
2 other devices also cite its predicate P810017.

How does its category compare?

All LYL devices

LYL 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

2007high 1 (2009) · low 0 (2007)2026

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

2007high 8 (2010) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LYL

4in 2025

2007high 10 (2011) · low 0 (2008)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 Lens Comfort Contact Lens Care Accessory is intended for use in conjunction with contact lens solutions as an accessory in the cleaning of contact lenses, Lens Comfort is indicated as aid for cleaning as an accessory for soft hydrophilic lenses and gas permeable lenses when used with the appropriate Barnes-Hind® Soft Mate® solutions such as the Consept® Cleaning and Disinfection System which is comprised of the Barnes-Hind® Soft Mate® Consept®-1…

Read the full statement (132 words)

The Lens Comfort Contact Lens Care Accessory is intended for use in conjunction with contact lens solutions as an accessory in the cleaning of contact lenses,

Lens Comfort is indicated as aid for cleaning as an accessory for soft hydrophilic lenses and gas permeable lenses when used with the appropriate Barnes-Hind® Soft Mate® solutions such as the Consept® Cleaning and Disinfection System which is comprised of the Barnes-Hind® Soft Mate® Consept®-1 Cleaning and Disinfecting solution and Barnes-Hind® Soft Mate® Consept®-2 Neutralizing and Rinsing Solution or Spray. The Lens Comfort Contact Lens Care Accessory is indicated for use for gas permeable solutions such as Barnes-Hind® Gas Permeable Daily Cleaner and Barnes-Hind® ComfortCure GP Wetting and Soaking Solution. The Lens 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/K962112 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962112: New Comfort Contact Lens Care Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962112

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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