# K974724: Softmate Automatic Lens Cleaning Unit, Clensatron 700 CL Automatic Contact Lens Cleaner, Visonic Dome, Lensonic Contact

- Pathway: 510(k) (Traditional)
- Applicant: Lens Comfort, Inc.
- Decided: Mar 2, 1998 after 74 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: 2 generations back to P840068 (1985). 8 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 11 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.
- P840066: Soft Mate (R) Hydrogen Peroxide Disinfection System, Advanced Medical Optics, Inc.. FDA lists this PMA only through its supplements; the earliest we hold is P840066/S002 (Dec 1, 1986). Summary page 1.
- K852386: Soft Mate Automatic Contact Lens Cleaning Unit, Barnes-Hind, Inc. (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) Summary page 1.
- K921615: Lensonic (TM) Contact Lens Care Accessory, Personal Professional Products, Inc. (1992) Summary page 1.
- K962112: New Comfort Contact Lens Care Accessory, Lens Comfort, Inc. (1996) Summary page 1.

## Most influential descendants
- 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 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.

Source page: https://510kreport.com/device/K974724
Methodology: https://510kreport.com/methodology