K242389
- 510(k) number
- K242389
- Device name
- EyeGility Inserter for Preloaded enVista IOLs
- Applicant
- Bausch & Lomb, Incorporated NY · US
- Product code
- MSS — Folders And Injectors, Intraocular Lens (Iol)
- Decision date
- 2024-10-10
- Date received
- 2024-08-12
- 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: K242389.pdf
Official FDA record: K242389
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.