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FDA 510(k)

RxSight Contact Lens

K-Number: K201909 · 2020-09-10

ApplicantRxsight, Inc.
Decision Date2020-09-10
Product CodeHJK
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RxSight Contact Lens is a medical device manufactured by Rxsight, Inc.. It received FDA 510(k) clearance on 2020-09-10 under approval number K201909. The device is classified under product code HJK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RxSight Contact Lens?

RxSight Contact Lens is a medical device that received FDA 510(k) clearance on 2020-09-10. It is manufactured by Rxsight, Inc.. The 510(k) number is K201909.

When was RxSight Contact Lens approved by the FDA?

RxSight Contact Lens received FDA 510(k) clearance on 2020-09-10, under approval number K201909.

What company makes RxSight Contact Lens?

RxSight Contact Lens is manufactured by Rxsight, Inc..

What is the FDA product code for RxSight Contact Lens?

The FDA product code for RxSight Contact Lens is HJK.

Other Devices by Rxsight, Inc.

K181401RxSight Insertion Device K192926RxSight Insertion Device K231838RxSight® Insertion Device (63002) K231466RxSight Insertion Device PMA P160055Light adjustable lens (LAL) and light delivery device (LDD)

Related Devices (Code: HJK)

K173944Endocular Viewing Lenses and Silicone RingPhakos

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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