K243588
- 510(k) number
- K243588
- Device name
- Single Use CO2 Laser Fiber (HAF005001)
- Applicant
- Quanta System Spa IT
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-02-19
- Date received
- 2024-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K243588.pdf
Official FDA record: K243588
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.