# K990568: Scrambled Endooto Laser Probe, Straight Tip, Model 59.02, Scrambled Endooto Laser Probe Bent Tip, Model 59.01

- Pathway: 510(k) (Traditional)
- Applicant: Synergetics, Inc.
- Decided: May 14, 1999 after 80 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
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
The Synergetics Inc., Mode Scrambled LEndoOto Laser Probe provides a means of delivering photocoagulation during otologic surgery. Indications includc, but are not limited to treatment of stapes related disorders to be treated with stapedectomy by means of photocoagulation. This device transmits laser energy to target tissuc, thereby causing photocoagulation. Spot size can be varied by altering the distance between the tissuc and the probe tip.

Source page: https://510kreport.com/device/K990568
Methodology: https://510kreport.com/methodology