# K012530: AA-1 System

- Pathway: 510(k) (Traditional)
- Applicant: Neurovision, Inc.
- Decided: Aug 31, 2001 after 25 days
- Product code: HJT (Haploscope)
- Device class: 1
- Regulation: 21 CFR 886.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K841599 (1984). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K852639: Humphrey Field Analyzer Model 630, Zeiss Humphrey System (1985) Summary page 2.
- K896171: Eye Patch, Eye Garter Company, Inc. (1989) Summary page 2.
- K841599: Storz Universal Eye Shield, Storz Instrument Co. (1984) Summary page 2.
- (no number) ophthalmic Haploscope: named in the summary without a submission number

## Most influential descendants
- K023623: Novavision, Model 2.0 (2003), 0 descendants of its own

## Indications for use
The Vision Treatment System is indicated for the treatment of amblyopia using an interactive computerized program in patients 9 years or older suffering from amblyopia.

Source page: https://510kreport.com/device/K012530
Methodology: https://510kreport.com/methodology