K243729
- 510(k) number
- K243729
- Device name
- Prismira
- Applicant
- Lumos Labs, Inc. CA · US
- Product code
- QFT — Digital Therapeutic Software For Attention Deficit H
- Decision date
- 2025-06-13
- Date received
- 2024-12-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243729.pdf
Official FDA record: K243729
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.