K230954
- 510(k) number
- K230954
- Device name
- Samfilcon B Custom Contact Lens
- Applicant
- Bausch + Lomb, Incorporated NY · US
- Product code
- LPL — Lenses, Soft Contact, Daily Wear
- Decision date
- 2023-11-17
- Date received
- 2023-04-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K230954.pdf
Official FDA record: K230954
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.