# K182984: MaxiTears Contacts PF

- Pathway: 510(k) (Traditional)
- Applicant: Omnivision AG
- Decided: Jul 24, 2019 after 268 days
- Product code: MRC (Products, Contact Lens Care, Rigid Gas Permeable)
- Device class: 2
- Regulation: 21 CFR 886.5918
- 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 K032030 (2003). 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)
- K032030: Blink CL Lubricant Eye Drops, Advanced Medical Optics, Inc. (2003) Summary page 5.

## Indications for use
MaxiTears® CONTACTS PF eye drops have been formulated for use with both soft and rigid gas permeable (RGP) contact lenses, to rewet lenses before insertion and lubricate lenses during wear. It also relieves minor irritation, discomfort, dryness, blurring and itchiness, which may occur while wearing your lenses.

Source page: https://510kreport.com/device/K182984
Methodology: https://510kreport.com/methodology