# K943543: Medical Optics CO2 Surgical Laser Systems

- Pathway: 510(k) (Traditional)
- Applicant: Medical Options, Inc.
- Decided: Dec 2, 1994 after 133 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.
18 later devices descend from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K992472: Sureguide CO2 Laser Beam Delivery System (1999), 17 descendants of its own
- K014048: Clinicon Universal Waveguide Handpiece and Fiber Tips (2002), 15 descendants of its own
- K050541: Omniguide Beampath CO2 Mark I Laser Beam Delivery (2005), 14 descendants of its own
- K070157: Omniguide Beam Path CO2 Mark Iii Waveguide Fiber (2007), 8 descendants of its own
- K073313: Mark Iii Waveguide Fiber with Low Profile Tip (2008), 5 descendants of its own

Source page: https://510kreport.com/device/K943543
Methodology: https://510kreport.com/methodology