Rxsight, Inc. FDA Approvals

0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
RxSight® Insertion Device510(k)Jun 10, 2026Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Special)	Jun 10, 2026
RxSight® Insertion Device (63002)510(k)Aug 15, 2023Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Aug 15, 2023
RxSight Insertion Device510(k)Jun 12, 2023Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Special)	Jun 12, 2023