# K991479: Viser Penile Tumescence Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Laborie Medical Tech Corp.
- Decided: Jul 7, 1999 after 70 days
- Product code: LIL (Monitor, Penile Tumescence)
- Device class: U
- 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
The VISER™ penile tumescence monitor is a non-invasive monitoring device used to measure intracavernosal pressure (ICP) and blood flow in the penis. This monitoring assists the physician in the diagnosis of erectile dysfunction. VISER™ is a prescriptive device to be used under the direction of a physician or other authorized health care professional.

Source page: https://510kreport.com/device/K991479
Methodology: https://510kreport.com/methodology