# K041008: Eye-Cept Rewetting Drops

- Pathway: 510(k) (Traditional)
- Applicant: Optics Laboratory, Inc.
- Decided: Jul 1, 2005 after 438 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Use EYE-CEPT® Rewetting Drops while wearing your lenses to moisten and rehydrate them. Also, use EYE-CEPT Rewetting Drops to relieve minor irritation, discomfort and/or blurring which may occur while wearing your lenses.

Source page: https://510kreport.com/device/K041008
Methodology: https://510kreport.com/methodology