K250206
- 510(k) number
- K250206
- Device name
- Diode laser system (Night Universe; Predator)
- Applicant
- Ivylaser (Beijing) Technology Co.,Ltd CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-04-24
- Date received
- 2025-01-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250206.pdf
Official FDA record: K250206
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.