# K935495: PF404/409/410/411/416/418 W/PF319:0/319:1/319:2

- Pathway: 510(k) (Traditional)
- Applicant: Perimed, Inc.
- Decided: Apr 18, 1994 after 154 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K974285: Periflux System 5000 Modular Laser Doppler System Main Unit Model PF 5001, Including PF 5010 LDPM Unit (1998), 2 descendants of its own
- K152930: PeriFlux6000 (2016), 1 descendant of its own
- K243852: Elfor-L (2025), 0 descendants of its own

Source page: https://510kreport.com/device/K935495
Methodology: https://510kreport.com/methodology