K241092
- 510(k) number
- K241092
- Device name
- Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT
- Applicant
- Quanta System Spa IT
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-10-10
- Date received
- 2024-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K241092.pdf
Official FDA record: K241092
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.