# K133019: Fiberion Ophthalmic Endolaser Probe

- Pathway: 510(k) (Traditional)
- Applicant: Emtron Elektronik VE Mekanik Sanayi VE Ticaret Lim
- Decided: Feb 20, 2015 after 512 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K894841 (1989). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022228: Family of Iris Medical Endoprobe Handpieces, Iridex Corp (2002) Summary page 5.

## Indications for use
Fiberion Ophthalmic Endolaser Probes are intended for use in performing ophthalmic laser treatments to deliver laser energy to the treatment area inside the eye, the illumination function is indicated for use to illuminate the interior of the eye. The probes are offered with straight or angled tips, and with a series of connectors that allows them to be used with compatible laser systems. The probes are cleared for use for the particular indications of the laser system to which they are attached

Source page: https://510kreport.com/device/K133019
Methodology: https://510kreport.com/methodology