# K113390: Laser Indirect Ophthalmoscope 500(Lio-500)

- Pathway: 510(k) (Traditional)
- Applicant: Meridian AG
- Decided: Feb 14, 2012 after 90 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- 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 K925642 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013402: Visulas 532S, Carl Zeiss, Inc. (2001) Summary page 1.

## Indications for use
The Laser Indirect Ophthalmoscope 500 (LIO-500) is intended for use in photocoagulating ocular tissue in the treatment of diseases of the eye. The laser energy is delivered via either transpupillary delivery or intraocular endoprobe delivery.

Source page: https://510kreport.com/device/K113390
Methodology: https://510kreport.com/methodology