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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 the device name listed in this FDA 510(k) record. The listed applicant is Rxsight, Inc.. It received FDA 510(k) clearance on 2020-09-10 under 510(k) 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. The listed applicant is Rxsight, Inc.. The 510(k) number is K201909.

When did RxSight Contact Lens receive FDA 510(k) clearance?

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

Who is the listed applicant for RxSight Contact Lens?

The FDA 510(k) record lists Rxsight, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RxSight Contact Lens?

The FDA product code for RxSight Contact Lens is HJK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07347379Long-Term Clinical Outcomes Of Subjects Enrolled In The RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment StudyENROLLING_BY_INVITATION

Other records listing Rxsight, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMA P160055Light adjustable lens (LAL) and light delivery device (LDD)K261174RxSight® Insertion DeviceK231838RxSight® Insertion Device (63002)K231466RxSight Insertion DeviceK192926RxSight Insertion DeviceK181401RxSight Insertion Device

View all 7 devices →

Related Devices (Code: HJK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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