K243445
- 510(k) number
- K243445
- 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
- 2024-12-30
- Date received
- 2024-11-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243445
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.