# K003442: Modification to Edi Veris System

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Diagnostic Imaging, Inc.
- Decided: May 4, 2001 after 179 days
- Product code: HLX (Photostimulator, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K023525: Retiscan, Retiport (2004), 6 descendants of its own
- K211643: Vision Monitor - MonpackONE (2021), 1 descendant of its own
- K081591: Neucodia (2009), 1 descendant of its own
- K221471: E3 and Profile (2022), 0 descendants of its own
- K212936: Vision Monitor- MonCvONE (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K003442
Methodology: https://510kreport.com/methodology