K261174
- 510(k) number
- K261174
- Device name
- RxSight® Insertion Device
- Applicant
- Rxsight, Inc. CA · US
- Product code
- MSS — Folders And Injectors, Intraocular Lens (Iol)
- Decision date
- 2026-06-10
- Date received
- 2026-04-09
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Ophthalmic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K261174.pdf
Official FDA record: K261174
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.