K261094
- 510(k) number
- K261094
- Device name
- YellowStar
- Applicant
- Asclepion Laser Technologies GmbH DE
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-04-29
- Date received
- 2026-04-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K261094.pdf
Official FDA record: K261094
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.