# K023623: Novavision, Model 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Novavision, Inc.
- Decided: Apr 22, 2003 after 175 days
- Product code: HPT (Perimeter, Automatic, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.1605
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K841599 (1984). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911938: Dynavision 2000, Performance Ent. (1991) Summary page 5.
- K012530: AA-1 System, Neurovision, Inc. (2001) Summary page 5.

## Indications for use
NovaVisionm is intended for the diagnosis and improvement of visual functions in patients with impaired vision that may result from trauma, stroke, inflammation, surgical removal of brain tumors or brain surgery, and may also be used to improve visual function in patients with amblyopia.

Source page: https://510kreport.com/device/K023623
Methodology: https://510kreport.com/methodology