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FDA 510(k)

Easy-Load Lens Delivery System

K-Number: K161012 · 2016-07-06

ApplicantBausch and Lomb, Inc.,
Decision Date2016-07-06
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Easy-Load Lens Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Bausch and Lomb, Inc.,. It received FDA 510(k) clearance on 2016-07-06 under 510(k) number K161012. 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 Easy-Load Lens Delivery System?

Easy-Load Lens Delivery System is a medical device that received FDA 510(k) clearance on 2016-07-06. The listed applicant is Bausch and Lomb, Inc.,. The 510(k) number is K161012.

When did Easy-Load Lens Delivery System receive FDA 510(k) clearance?

Easy-Load Lens Delivery System received FDA 510(k) clearance on 2016-07-06, under 510(k) number K161012.

Who is the listed applicant for Easy-Load Lens Delivery System?

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

What is the FDA product code for Easy-Load Lens Delivery System?

The FDA product code for Easy-Load Lens Delivery System is MSS.

Other records listing Bausch and Lomb, 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.

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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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