K240611
- 510(k) number
- K240611
- Device name
- IVYLASER Diode laser hair removal system (IVY-HR-Alloy)
- Applicant
- Ivylaser (Beijing) Technology Co.,Ltd CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-06-20
- Date received
- 2024-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K240611.pdf
Official FDA record: K240611
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.