# K060905: Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1

- Pathway: 510(k) (Traditional)
- Applicant: Iridex Corp
- Decided: May 31, 2006 after 58 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: 3 generations back to K904627 (1991). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990174: Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite, Model E-80-II, Elite Ultra, Model E-80-IV, Fisma, Inc. (1999) Summary page 1.
- K943445: Megabeam Fiber Optic Delivery System, Ceram Optec, Inc. (1994) Summary page 1.
- K980389: Megabeam Reusable Fiber Optic Handpiece and Needles, Ceram Optec, Inc. (1998) Summary page 1.
- K952772: Megabeam Endo-Ent Probe, Ceram Optec, Inc. (1995) Summary page 1.

## Indications for use
The IRIDEX OtoProbe is intended for use in surgical procedures for use in incision, excision, coagulation, and vaporization of soft and fibrous tissue including osseous tissue in the medical specialty of ENT surgery. The IRIDEX OtoProbe is cleared for use for the particular indications of the compatible laser system to which it is attached.

Source page: https://510kreport.com/device/K060905
Methodology: https://510kreport.com/methodology