# K222541: Bausch + Lomb Preservative Free Lubricating and Rewetting Drops

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Incorporated
- Decided: Dec 6, 2022 after 106 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 P830034/S016 (1990). 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)
- P830034/S016: Opti-Free Rewetting Drops & Storage Solution, Alcon Laboratories (1990). A supplement to the PMA, as the summary prints it. Summary page 4.

## Indications for use
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops are indicated for use to lubricate and rewet soft (hydrophilic) contact lenses, including silicone hydrogel as well as silicone acrylate (SA) and fluorosilicone acrylate (FSA) rigid gas permeable (RGP) contact lenses during wear. The product may be used with daily or extended wear, and disposable lenses.

Source page: https://510kreport.com/device/K222541
Methodology: https://510kreport.com/methodology