K243953
- 510(k) number
- K243953
- Device name
- Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
- Applicant
- Vizionfocus, Inc. TW
- Product code
- LPL — Lenses, Soft Contact, Daily Wear
- Decision date
- 2025-04-10
- Date received
- 2024-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K243953.pdf
Official FDA record: K243953
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.