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FDA 510(k)

BAUSCH & LOMB IOL INJECTOR

K-Number: K113852 · 2012-09-28

ApplicantBausch & Lomb, Inc.
Decision Date2012-09-28
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BAUSCH & LOMB IOL INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2012-09-28 under 510(k) number K113852. 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 BAUSCH & LOMB IOL INJECTOR?

BAUSCH & LOMB IOL INJECTOR is a medical device that received FDA 510(k) clearance on 2012-09-28. The listed applicant is Bausch & Lomb, Inc.. The 510(k) number is K113852.

When did BAUSCH & LOMB IOL INJECTOR receive FDA 510(k) clearance?

BAUSCH & LOMB IOL INJECTOR received FDA 510(k) clearance on 2012-09-28, under 510(k) number K113852.

Who is the listed applicant for BAUSCH & LOMB IOL INJECTOR?

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

What is the FDA product code for BAUSCH & LOMB IOL INJECTOR?

The FDA product code for BAUSCH & LOMB IOL INJECTOR is MSS.

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Other records listing Bausch & 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.

K192005Bausch + Lomb PreVue Inserter for enVista PreloadedK173480Crystalsert Lens Delivery SystemK161012Easy-Load Lens Delivery SystemK131208BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,K122575BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VIK112909OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION

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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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