# K942343: Laseaway Q-Switched Ruby Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Polytec Pi, Inc.
- Decided: Jul 8, 1994 after 53 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.
40 later devices descend from it; 1 cites it directly.
0 of 41 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
- K971193: Laseaway Long Pulse and Q-Switched Ruby Laser System (1997), 39 descendants of its own
- K121162: Polaris Q-Switch Ruby System (2012), 38 descendants of its own
- K152012: EVO platform (2015), 37 descendants of its own
- K160368: EVO platform (2016), 36 descendants of its own
- K163222: Discovery Pico Family (2016), 30 descendants of its own

Source page: https://510kreport.com/device/K942343
Methodology: https://510kreport.com/methodology