K242059
- 510(k) number
- K242059
- Device name
- Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)
- Applicant
- X-Cel Specialty Contacts, A Walman Optical Company GA · US
- Product code
- LPL — Lenses, Soft Contact, Daily Wear
- Decision date
- 2024-08-14
- Date received
- 2024-07-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K242059.pdf
Official FDA record: K242059
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.