K232139
- 510(k) number
- K232139
- Device name
- Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
- Applicant
- Innova Vision, Inc. TW
- Product code
- LPL — Lenses, Soft Contact, Daily Wear
- Decision date
- 2023-11-16
- Date received
- 2023-07-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K232139.pdf
Official FDA record: K232139
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.