# K922901: Incisor I Pulsed ND:Yag Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Buckman Co., Inc.
- Decided: Nov 20, 1992 after 157 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.
320 later devices descend from it; 2 cite it directly.
0 of 321 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
- K972325: Pulsemaster 1000 ST Dental Laser System (1997), 318 descendants of its own
- K991994: Twilight (1999), 280 descendants of its own
- K012511: Waterlase Millennium (2002), 246 descendants of its own
- K974641: Futurelase 3000/3002 Erbium Laser System (1998), 241 descendants of its own
- K021508: Opusduo EC Dental Laser System (2002), 240 descendants of its own

Source page: https://510kreport.com/device/K922901
Methodology: https://510kreport.com/methodology