K260138
- 510(k) number
- K260138
- Device name
- LUNE PureHygiene
- Applicant
- Enamel Pure MA · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-05-29
- Date received
- 2026-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K260138.pdf
Official FDA record: K260138
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.