K260489
- 510(k) number
- K260489
- Device name
- LASEmaR 1500
- Applicant
- Eufoton S.R.L. IT
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-05-29
- Date received
- 2026-02-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260489.pdf
Official FDA record: K260489
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.