K241407
- 510(k) number
- K241407
- Device name
- Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
- Applicant
- Bios S.R.L. IT
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-06-14
- Date received
- 2024-05-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K241407.pdf
Official FDA record: K241407
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.