# K260138: LUNE PureHygiene

- Pathway: 510(k) (Traditional)
- Applicant: Enamel Pure
- Decided: May 29, 2026 after 133 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: 21 generations back to K943450 (1995). 241 ancestors in all.
No later device cites it as a predicate yet.
0 of 242 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K234085: LUNE™ PureHygiene, Enamel Pure (2024) Summary page 5.

## Indications for use
Enamel Pure Lune PureHygiene is indicated for the following in hard tissue: » Reduction of bacterial level (decontamination) » Aiding in the reduction of mineral loss in dental enamel

Source page: https://510kreport.com/device/K260138
Methodology: https://510kreport.com/methodology