FDA 510(k)

RxSight® Insertion Device (63002)

K-Number: K231838 · 2023-08-15

Decision Date2023-08-15

Product CodeMSS

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

RxSight® Insertion Device (63002) is a medical device manufactured by Rxsight, Inc.. It received FDA 510(k) clearance on 2023-08-15 under approval number K231838. 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 (63002)?

RxSight® Insertion Device (63002) is a medical device that received FDA 510(k) clearance on 2023-08-15. It is manufactured by Rxsight, Inc.. The 510(k) number is K231838.

When was RxSight® Insertion Device (63002) approved by the FDA?

RxSight® Insertion Device (63002) received FDA 510(k) clearance on 2023-08-15, under approval number K231838.

What company makes RxSight® Insertion Device (63002)?

RxSight® Insertion Device (63002) is manufactured by Rxsight, Inc..

What is the FDA product code for RxSight® Insertion Device (63002)?

The FDA product code for RxSight® Insertion Device (63002) is MSS.

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Other Devices by Rxsight, Inc.

K181401RxSight Insertion Device K201909RxSight Contact Lens K192926RxSight Insertion Device 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

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