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FDA 510(k)

RxSight® Insertion Device

K-Number: K261174 · 2026-06-10

ApplicantRxsight, Inc.
Decision Date2026-06-10
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RxSight® Insertion Device is the device name listed in this FDA 510(k) record. The listed applicant is Rxsight, Inc.. It received FDA 510(k) clearance on 2026-06-10 under 510(k) number K261174. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RxSight® Insertion Device?

RxSight® Insertion Device is a medical device that received FDA 510(k) clearance on 2026-06-10. The listed applicant is Rxsight, Inc.. The 510(k) number is K261174.

When did RxSight® Insertion Device receive FDA 510(k) clearance?

RxSight® Insertion Device received FDA 510(k) clearance on 2026-06-10, under 510(k) number K261174.

Who is the listed applicant for RxSight® Insertion Device?

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® Insertion Device?

The FDA product code for RxSight® Insertion Device is MSS.

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)K231838RxSight® Insertion Device (63002)K231466RxSight Insertion DeviceK201909RxSight Contact LensK192926RxSight Insertion DeviceK181401RxSight Insertion Device

View all 7 devices →

Related Devices (Code: MSS)

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.

K252540ACCUJECT Injector Set 2.1-1P (LP604590)Medicel AGK242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, IncorporatedK231106Accuject Refra Injector AR2900Medicel AGK231838RxSight® Insertion Device (63002)Rxsight, Inc.K231466RxSight Insertion DeviceRxsight, Inc.K212039CLAREON MONARCH IV IOL Delivery SystemAlcon Laboratories, Inc.

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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