# K211361: 3N Contact Lenses Adjunct Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou 3N Biological Technology Co., Ltd.
- Decided: Jan 13, 2022 after 255 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: 4 generations back to P840068 (1985). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982115: Lenserver Automatic Contact Lens Cleaning Accessory, Rim-Wide Companies, Inc. (1999) Summary page 4.

## Indications for use
3N Contact Lenses Adjunct Cleaner is intended for use as an adjunct in deproteinization and storage for soft hydrophilic contact lenses with only either OPTI-FREE EXPRESS Multi-Purpose Disinfecting Solution or Bausch & Lomb ReNu MultiPlus Multi-Purpose Solution.

Source page: https://510kreport.com/device/K211361
Methodology: https://510kreport.com/methodology