K240132
- 510(k) number
- K240132
- Device name
- EmoLED (v. 2-USA)
- Applicant
- Emoled, Srl IT
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-03-12
- Date received
- 2024-01-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 5.4 MB · U.S. public domain
Also available from FDA: K240132.pdf
Official FDA record: K240132
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.