# K962112: New Comfort Contact Lens Care Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Lens Comfort, Inc.
- Decided: Nov 29, 1996 after 182 days
- Product code: LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses)
- Device class: 2
- Regulation: 21 CFR 886.5928
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P840068 (1985). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P810017: Soft Mate Weekly Cleaning Solution, Advanced Medical Optics, Inc.. FDA lists this PMA only through its supplements; the earliest we hold is P810017/S001 (Mar 25, 1982). Summary page 1.
- P840068: Delta Pacemaker Sys; Vigor DDD Model 950, Boston Scientific (1985) Summary page 1.
- K884414: Clensatron Automatic Contact Lens Cleaner, Questech Intl., Inc. (1988) Summary page 1.
- K902306: The Visonic Dome (TM), Vista Vision (1990)

## Cited in the summary but kept off the family tree
- K882388: MR. Razor II Twin, Burney Products Corp. (1988). 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.
- K821815: Advance C-Reactive Protein (CRP) Assay, Syva Co. (1982). 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.

## Most influential descendants
- K974724: Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact Lens Cleaner, Visonic Dome, Lensonic Contact (1998), 4 descendants of its own
- K982115: Lenserver Automatic Contact Lens Cleaning Accessory (1999), 3 descendants of its own
- K021699: Autolens Cleaning and Disinfecting Unit (2002), 1 descendant of its own
- K211361: 3N Contact Lenses Adjunct Cleaner (2022), 0 descendants of its own
- K210300: VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System (2021), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K962112
Methodology: https://510kreport.com/methodology