# K951910: Odyssey HO:Yag Surgical Laser Systems & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Xintec Corporation
- Decided: Dec 27, 1995 after 247 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.
480 later devices descend from it; 3 cite it directly.
0 of 481 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices (2001), 342 descendants of its own
- K060114: Vectra Laser System (2006), 233 descendants of its own
- K072106: 150W Ceralas D 980NM Diode Laser (2007), 229 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (2009), 177 descendants of its own

Source page: https://510kreport.com/device/K951910
Methodology: https://510kreport.com/methodology