K240512
- 510(k) number
- K240512
- Device name
- Tixel i (TXLI0001)
- Applicant
- Novoxel , Ltd. IL
- Product code
- ORZ — Eyelid Thermal Pulsation System
- Decision date
- 2024-11-04
- Date received
- 2024-02-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K240512.pdf
Official FDA record: K240512
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.