# K912703: Optica 60 ND;Yag Surgical Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Xintec Corporation
- Decided: Oct 11, 1991 after 114 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.
728 later devices descend from it; 2 cite it directly.
0 of 729 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
- K962791: New Star Model 130 6-Watt ND: Yag Laser System (1997), 726 descendants of its own
- K014035: Cooltouch and Cooltouch-II ND:Yag Laser Systems (2002), 668 descendants of its own
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K022817: Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag Laser System, Model Cooltouch-II (2002), 575 descendants of its own
- K022466: Profile 1320 Laser System (2002), 520 descendants of its own

Source page: https://510kreport.com/device/K912703
Methodology: https://510kreport.com/methodology