# K110205: Aaio-7, Aaio Wirless

- Pathway: 510(k) (Traditional)
- Applicant: Appasamy Associates
- Decided: Feb 9, 2011 after 15 days
- Product code: HLI (Ophthalmoscope, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
AAIO-7 &,AAIO Wireless, is a head mounted Binocular Indirect ophthalmoscope designed to be Used by trained personnel for illuminating and viewing parts of the eye such as the. Cornea and retina when used in conjunction with an ophthalmic lens. Binocular Indirect Ophthalmoscope provides an illumination system to direct appropriately, focused light into the eye in order to obtain an intermediate image of the fundus (retina) that is viewed by the observer to diagnose the eye.

Source page: https://510kreport.com/device/K110205
Methodology: https://510kreport.com/methodology