# K022803: Waterlase for Apicoectomy

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Feb 3, 2003 after 164 days
- Product code: MXF (System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 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
- K030523: Waterlase (2004), 8 descendants of its own
- K052354: Oculase MD (2006), 5 descendants of its own
- K063867: Cutera ER:Ysgg Laser Handpiece (2007), 2 descendants of its own
- K080530: Modification to Cutera ER:Ysgg Laser Handpiece (2008), 1 descendant of its own
- K081589: Waterlase, Version 3.0 (2008), 1 descendant of its own

Source page: https://510kreport.com/device/K022803
Methodology: https://510kreport.com/methodology