# K921671: Surgilase Fiberlase VCO2 Laser Waveguide

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Products Corp.
- Decided: Jun 18, 1992 after 71 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.
19 later devices descend from it; 3 cite it directly.
0 of 20 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
- 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
- K100384: Fiberlase C02 Laser Waveguide (2010), 5 descendants of its own
- K073313: Mark Iii Waveguide Fiber with Low Profile Tip (2008), 5 descendants of its own
- K093451: Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss Tip (2009), 4 descendants of its own

Source page: https://510kreport.com/device/K921671
Methodology: https://510kreport.com/methodology