# K994170: Hylashield CL

- Pathway: 510(k) (Traditional)
- Applicant: Biomatrix, Inc.
- Decided: Mar 2, 2000 after 83 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
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. The FDA summary names its predicate without a number.
- (no number) Wet-N-Soak® Rewetting Drops: named in the summary without a submission number
- (no number) OPTIMUM by Lobob® Wetting/Rewetting Drops: named in the summary without a submission number

## Indications for use
Hylashield® CL Lubricating Eye Drops are indicated for lubricating and wetting/rewetting rigid gas permeable contact lenses.

Source page: https://510kreport.com/device/K994170
Methodology: https://510kreport.com/methodology