# K234085: LUNE™ PureHygiene

- Pathway: 510(k) (Traditional)
- Applicant: Enamel Pure
- Decided: Mar 25, 2024 after 94 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: 20 generations back to K943450 (1995). 240 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 242 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193486: Epic 980, Biolase, Inc. (2020) Summary page 5.

## Most influential descendants
- K260138: LUNE PureHygiene (2026), 0 descendants of its own

## Indications for use
Enamel Pure LUNE PureHygiene is indicated for the following in dental hard tissue: • Reduction of bacterial level (decontamination)

Source page: https://510kreport.com/device/K234085
Methodology: https://510kreport.com/methodology