# K071363: Waterlase and Waterlase MD

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Feb 12, 2008 after 273 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
Longest line of descent: 3 generations back to K003422 (2001). 3 ancestors in all.
28 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053167: Biopure Mtad Root Canal Cleanser, Dentsply Intl., Inc. (2005) Summary page 2.
- K032361: Endopure Root Canal Cleanser, Dentsply Intl. (2004) Summary page 2.
- (no number) Waterlase®: named in the summary without a submission number

## Most influential descendants
- K090181: Waterlase MD (2009), 26 descendants of its own
- K101658: Waterlase MD Turbo Plus Model 7200XXX (2010), 25 descendants of its own
- K161669: Waterlase Express (2016), 21 descendants of its own
- K190319: Waterlase Laser System Family (2019), 19 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own

## Indications for use
Root Canal Disinfection Laser root canal disinfection after endodontic instrumentation

Source page: https://510kreport.com/device/K071363
Methodology: https://510kreport.com/methodology