K232813
- 510(k) number
- K232813
- Device name
- Therapy EC, Therapy XT
- Applicant
- Dmc Importacao E Exportacao DE Equipamentos Ltda BR
- Product code
- NHN — Powered Light Based Laser Non-Thermal Instrument Wit
- Decision date
- 2024-12-19
- Date received
- 2023-09-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232813.pdf
Official FDA record: K232813
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.