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FDA 510(k)

RxSight Insertion Device

K-Number: K192926 · 2020-01-17

ApplicantRxsight, Inc.
Decision Date2020-01-17
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RxSight Insertion Device is a medical device manufactured by Rxsight, Inc.. It received FDA 510(k) clearance on 2020-01-17 under approval number K192926. 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 2020-01-17. It is manufactured by Rxsight, Inc.. The 510(k) number is K192926.

When was RxSight Insertion Device approved by the FDA?

RxSight Insertion Device received FDA 510(k) clearance on 2020-01-17, under approval number K192926.

What company makes RxSight Insertion Device?

RxSight Insertion Device is manufactured by Rxsight, Inc..

What is the FDA product code for RxSight Insertion Device?

The FDA product code for RxSight Insertion Device is MSS.

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Other Devices by Rxsight, Inc.

K181401RxSight Insertion Device K201909RxSight Contact Lens K231838RxSight® Insertion Device (63002) K231466RxSight Insertion Device PMA P160055Light adjustable lens (LAL) and light delivery device (LDD)

Related Devices (Code: MSS)

K161776Lenstec LC Injection systemLenstec, Inc. K161012Easy-Load Lens Delivery SystemBausch and Lomb, Inc., K172228pioli IOL Delivery SystemAst Products, Inc. K173480Crystalsert Lens Delivery SystemBausch & Lomb, Inc. K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company K181401RxSight 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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