K232133
- 510(k) number
- K232133
- Device name
- Co2 Laser System, Models: PureLase And VanLase
- Applicant
- Cpmt Laser (Canadian Pioneer Medical Technology Corporation) CA
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-04-16
- Date received
- 2023-07-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232133.pdf
Official FDA record: K232133
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.