Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CLAREON MONARCH IV IOL Delivery System

K-Number: K212039 · 2021-08-23

ApplicantAlcon Laboratories, Inc.
Decision Date2021-08-23
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CLAREON MONARCH IV IOL Delivery System is a medical device manufactured by Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2021-08-23 under approval number K212039. 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 CLAREON MONARCH IV IOL Delivery System?

CLAREON MONARCH IV IOL Delivery System is a medical device that received FDA 510(k) clearance on 2021-08-23. It is manufactured by Alcon Laboratories, Inc.. The 510(k) number is K212039.

When was CLAREON MONARCH IV IOL Delivery System approved by the FDA?

CLAREON MONARCH IV IOL Delivery System received FDA 510(k) clearance on 2021-08-23, under approval number K212039.

What company makes CLAREON MONARCH IV IOL Delivery System?

CLAREON MONARCH IV IOL Delivery System is manufactured by Alcon Laboratories, Inc..

What is the FDA product code for CLAREON MONARCH IV IOL Delivery System?

The FDA product code for CLAREON MONARCH IV IOL Delivery System is MSS.

Related Clinical Trials

NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING NCT06847542 A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD RECRUITING

Other Devices by Alcon Laboratories, Inc.

K161391DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives K161288LenSX Laser System K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc K162596AIR OPTIX COLORS K160609AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric K153642DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal

View all 43 devices →

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.

↑