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FDA 510(k)

Accuject Refra Injector AR2900

K-Number: K231106 · 2023-09-19

ApplicantMedicel AG
Decision Date2023-09-19
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Accuject Refra Injector AR2900 is a medical device manufactured by Medicel AG. It received FDA 510(k) clearance on 2023-09-19 under approval number K231106. 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 Accuject Refra Injector AR2900?

Accuject Refra Injector AR2900 is a medical device that received FDA 510(k) clearance on 2023-09-19. It is manufactured by Medicel AG. The 510(k) number is K231106.

When was Accuject Refra Injector AR2900 approved by the FDA?

Accuject Refra Injector AR2900 received FDA 510(k) clearance on 2023-09-19, under approval number K231106.

What company makes Accuject Refra Injector AR2900?

Accuject Refra Injector AR2900 is manufactured by Medicel AG.

What is the FDA product code for Accuject Refra Injector AR2900?

The FDA product code for Accuject Refra Injector AR2900 is MSS.

Other Devices by Medicel AG

K252540ACCUJECT Injector Set 2.1-1P (LP604590)

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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