Medical Device Manufacturer · US , Aliso Viejo , CA

Rxsight, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2018

Recent clearances: RxSight® Insertion Device (63002), RxSight Insertion Device, RxSight Contact Lens

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rxsight, Inc. Ophthalmic ✕

6 devices

1-6 of 6

Cleared Jun 10, 2026

RxSight® Insertion Device

Ophthalmic · 62d

Cleared Aug 15, 2023

RxSight® Insertion Device (63002)

Ophthalmic · 54d

Cleared Jun 12, 2023

RxSight Insertion Device

Ophthalmic · 24d

Cleared Sep 10, 2020

RxSight Contact Lens

Ophthalmic · 63d

Cleared Jan 17, 2020

RxSight Insertion Device

Ophthalmic · 93d

Cleared Jul 26, 2018

RxSight Insertion Device

Ophthalmic · 58d