K240159
- 510(k) number
- K240159
- Device name
- InnoVoyce VYLO
- Applicant
- Innovoyce MA · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-05-29
- Date received
- 2024-01-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K240159.pdf
Official FDA record: K240159
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.