# K053044: Opto Global Digital Fundus Camera System Model Ads 1.5

- Pathway: 510(k) (Traditional)
- Applicant: Opto Global, Inc.
- Decided: Jan 24, 2006 after 88 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- 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 K011877 (2001). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021787: Visucam, Carl Zeiss Ophthalmic Systems, Inc. (2002) Summary page 1.
- K011877: FF450 Plus Fundus Camera and Visupac Digital Image Archiving System, or FF450 Plus Visupac System, Carl Zeiss Jena GmbH (2001) Summary page 1.
- (no number) Imagenet Digital Ophthalmic Imaging: named in the summary without a submission number
- (no number) 50 EX Fundus camera: named in the summary without a submission number

## Most influential descendants
- K091064: Navilas Laser System (2009), 3 descendants of its own
- K141851: Navilas Laser System (2015), 2 descendants of its own
- K162191: NAVILAS Laser System (2016), 1 descendant of its own
- K251772: Navilas Laser System 577sl (156691) (2025), 0 descendants of its own

## Indications for use
The OPTO Global Digital Fundus Camera System Model ADS 1.5 is intended to be used to capture, archive, recall and display black and white, and color images of the retina, as well as surrounding areas, to aid in the diagnosis and monitoring of diseases of the eye that may be viewed and photographed non-invasively.

Source page: https://510kreport.com/device/K053044
Methodology: https://510kreport.com/methodology