Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2021-08-23 under 510(k) 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. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K212039.

When did CLAREON MONARCH IV IOL Delivery System receive FDA 510(k) clearance?

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

Who is the listed applicant for CLAREON MONARCH IV IOL Delivery System?

The FDA 510(k) record lists Alcon Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Alcon Laboratories, 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 P840064AID, SURGICAL, VISCOELASTICPMA P930014intraocular lensPMA P190018intraocular lensPMA P010019Lenses, soft contact, extended wearPMA P220007Lenses, soft contact, extended wearK254052DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal

View all 50 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.

↑