# K991965: Purilens System for Cleaning and Disinfecting Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Purilens, Inc.
- Decided: Oct 1, 1999 after 113 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P860023/S006: Bausch & Lomb (R) Renu (R) Multi-Purpose Solution, Bausch & Lomb, Inc. (1994). A supplement to the PMA, as the summary prints it.
- K962112: New Comfort Contact Lens Care Accessory, Lens Comfort, Inc. (1996) Summary page 2.
- K852386: Soft Mate Automatic Contact Lens Cleaning Unit, Barnes-Hind, Inc. (1985) Summary page 2.
- K884414: Clensatron Automatic Contact Lens Cleaner, Questech Intl., Inc. (1988) Summary page 2.

## Indications for use
The Purilens® System is indicated for the cleaning and disinfection of soft (hydrophilic) contact lenses by means of subsonic agitation to remove lens deposits and microorganisms, and ultraviolet irradiation of the surrounding storage solution for disinfection. The lenses may be stored in the disinfected solution for a period of 24 hours following the cleaning and disinfection cycle.

Source page: https://510kreport.com/device/K991965
Methodology: https://510kreport.com/methodology