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FDA 510(k)

MicroSTAAR Injector System Cartridges

K-Number: K172375 · 2017-09-06

ApplicantSTAAR Surgical Company
Decision Date2017-09-06
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MicroSTAAR Injector System Cartridges is the device name listed in this FDA 510(k) record. The listed applicant is STAAR Surgical Company. It received FDA 510(k) clearance on 2017-09-06 under 510(k) number K172375. 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 MicroSTAAR Injector System Cartridges?

MicroSTAAR Injector System Cartridges is a medical device that received FDA 510(k) clearance on 2017-09-06. The listed applicant is STAAR Surgical Company. The 510(k) number is K172375.

When did MicroSTAAR Injector System Cartridges receive FDA 510(k) clearance?

MicroSTAAR Injector System Cartridges received FDA 510(k) clearance on 2017-09-06, under 510(k) number K172375.

Who is the listed applicant for MicroSTAAR Injector System Cartridges?

The FDA 510(k) record lists STAAR Surgical Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MicroSTAAR Injector System Cartridges?

The FDA product code for MicroSTAAR Injector System Cartridges is MSS.

Related Clinical Trials

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.

NCT07790965Study of a Phakic Implantable Collamer Lens (ICL)NOT_YET_RECRUITINGNCT07791381Study of an Implantable Collamer Lens (ICL)NOT_YET_RECRUITING

Other records listing STAAR Surgical Company 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 P030016Lens, intraocular, phakic

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.

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