K243868
- 510(k) number
- K243868
- Device name
- Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
- Applicant
- Pegavision Corporation TW
- Product code
- LPL — Lenses, Soft Contact, Daily Wear
- Decision date
- 2025-07-02
- Date received
- 2024-12-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K243868.pdf
Official FDA record: K243868
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.