# K011561: Sereine Extra Strength Daily Cleaner

- Pathway: 510(k) (Traditional)
- Applicant: Wilsa, Inc.
- Decided: Nov 20, 2001 after 183 days
- Product code: LPN (Accessories, Soft Lens Products)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) MiraFlow Extra Strength Daily Cleaner, CIBA Vision Corporation: named in the summary without a submission number

## Most influential descendants
- K071203: Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (Sihy) Soft Contact Lenses (2007), 0 descendants of its own

## Indications for use
Sereine Extra Strength Daily Cleaner is indicated for use as a daily cleaner for removal of film, deposits and other debris which accumulate on soft (hydrophilic) and PMMA contact lenses during wear. Sereine Extra Strength Daily Cleaner may be used with either thermal (heat) or chemical (cold) disinfection systems. Follow the recommendation of your eye care practitioner when disinfecting your lenses.

Source page: https://510kreport.com/device/K011561
Methodology: https://510kreport.com/methodology