# K071203: Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (Sihy) Soft Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Optikem International, Inc.
- Decided: Jun 13, 2007 after 43 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
Longest line of descent: 1 generation back to K011561 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011561: Sereine Extra Strength Daily Cleaner, Wilsa, Inc. (2001) Summary page 4.
- (no number) MIRAFLOW cleaner by CIBA Vision: named in the summary without a submission number

## Indications for use
The Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is a cleaner for removal of film, deposits and other accumulated debris, which accumulate on Silicone Hydrogel soft contact lenses during wear. Sereine Extra Strength Daily Cleaner for Silicone Hydrogel (SIHY) Soft Contact Lenses is to be used with a Multipurpose Solution indicated for Silicone Hydrogel soft contact lenses. Follow the recommendation of your eye care practitioner when disinfecting your lenses.

Source page: https://510kreport.com/device/K071203
Methodology: https://510kreport.com/methodology