K243819
- 510(k) number
- K243819
- Device name
- Luminopia
- Applicant
- Luminopia, Inc. MA · US
- Product code
- QQU — Digital Therapy Device For Amblyopia
- Decision date
- 2025-04-09
- Date received
- 2024-12-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K243819.pdf
Official FDA record: K243819
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.