# K091579: Foresee Home

- Pathway: 510(k) (Traditional)
- Applicant: Notal Vision, Ltd.
- Decided: Dec 23, 2009 after 204 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: 9 generations back to K864318 (1987). 38 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050350: The Notal Vision Preview Preferential Hyperacuity Perimeter (Preview PHP), Notal Vision, Inc. (2005) Summary page 1.
- K063609: River- 1 Electrocardiograph (Ecg) Recorder and Transmitter, Shl Telemedicine International, Ltd. (2007) Summary page 1.
- K053303: Cardiocom Commander Iii, Cardiocom, LLC (2005) Summary page 1.
- K071564: Motiva Monitor Device Connectivity, Model# 453564036921, Philips Medical Systems (2007) Summary page 1.
- (no number) Amsler Grid Chart: named in the summary without a submission number

## Most influential descendants
- K121738: Myvisiontrack (TM) (2013), 3 descendants of its own
- K143211: myVision Track Model 005 (2015), 2 descendants of its own
- K180895: Alleye (2018), 1 descendant of its own
- K203594: EyeCTester (2022), 0 descendants of its own

## Indications for use
The Foresce Home is intended for use in the detection and characterization of central and paracentral metamorphopsia (visual distortion) in patients with age-related macular degeneration, as an aid in monitoring progression of disease factors causing metamorphopsia including but not limited to choroidal neovascularization (CNV). It is intended to be used at home for patients with stable fixation.

Source page: https://510kreport.com/device/K091579
Methodology: https://510kreport.com/methodology