# K993883: M-Pact Corneal Light Shield

- Pathway: 510(k) (Traditional)
- Applicant: M-Pact Corp.
- Decided: Dec 21, 1999 after 36 days
- Product code: HOZ (Sponge, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4790
- 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) Merocel Corneal Sponge: named in the summary without a submission number

## Indications for use
The Corneal Light Shield is a sterile sponge that is not absorbable by the body. It is intended for short-term transient use by a physician to be placed on the surface of the cornea and shield the retina from illumination during ophthalmic procedures. The Corneal Light Shield is to be used once and discarded.

Source page: https://510kreport.com/device/K993883
Methodology: https://510kreport.com/methodology