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FDA 510(k)

RxSight Insertion Device

K-Number: K181401 · 2018-07-26

ApplicantRxsight, Inc.
Decision Date2018-07-26
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 2018-07-26 under 510(k) number K181401. 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 2018-07-26. The listed applicant is Rxsight, Inc.. The 510(k) number is K181401.

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

RxSight Insertion Device received FDA 510(k) clearance on 2018-07-26, under 510(k) number K181401.

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)K261174RxSight® Insertion DeviceK231838RxSight® Insertion Device (63002)K231466RxSight Insertion DeviceK201909RxSight Contact LensK192926RxSight 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.

K261174RxSight® Insertion DeviceRxsight, Inc.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.

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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