# K964222: Acu-Clens Cleaning System for Contact Lens Cleaning

- Pathway: 510(k) (Traditional)
- Applicant: Paladin Medical, Inc.
- Decided: Dec 20, 1996 after 59 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) The CLEANER™ Accessory by Easy Eyes, Eaton Medical Corporation: named in the summary without a submission number

## Most influential descendants
- K021699: Autolens Cleaning and Disinfecting Unit (2002), 1 descendant 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
ACU-CLENS™ Cleaning Accessory is indicated for use with recommended contact lens cleaning solutions for cleaning soft (hydrophilic) and rigid gas permeable contact lenses in accordance with directions for use in the solution labeling. The device aids in cleaning by minimizing hand contact with lenses.

Source page: https://510kreport.com/device/K964222
Methodology: https://510kreport.com/methodology