# K072995: Twinwave Dental Laser, Tidalwave 810 Dental Laser, Tidalwave 980 Dental Laser

- Pathway: 510(k) (Traditional)
- Applicant: Lumen Development and Manufacturing, Inc.
- Decided: Dec 18, 2007 after 56 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.
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
- K100474: Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5W (2010), 8 descendants of its own
- K152032: ELUMI 810 + 980 Soft Tissue Laser (2015), 7 descendants of its own
- K193486: Epic 980 (2020), 2 descendants of its own
- K192617: Gemini 810+980 Soft Tissue Laser (2020), 2 descendants of its own
- K234085: LUNE™ PureHygiene (2024), 1 descendant of its own

Source page: https://510kreport.com/device/K072995
Methodology: https://510kreport.com/methodology