K234085
- 510(k) number
- K234085
- Device name
- LUNE PureHygiene
- Applicant
- Enamel Pure MA · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-03-25
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K234085.pdf
Official FDA record: K234085
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.