# K011041: Waterlase, Millennium

- Pathway: 510(k) (Traditional)
- Applicant: Biolase Technology, Inc.
- Decided: Jul 3, 2001 after 89 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.
373 later devices descend from it; 4 cite it directly.
0 of 374 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
- K030539: Lasersmile (2003), 327 descendants of its own
- K061898: Ezlase (2007), 289 descendants of its own
- K072034: Diode Medical Laser Family, Models 4, 6, 30 (2007), 263 descendants of its own
- K021508: Opusduo EC Dental Laser System (2002), 240 descendants of its own
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum (2004), 226 descendants of its own

Source page: https://510kreport.com/device/K011041
Methodology: https://510kreport.com/methodology