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FDA 510(k)

EASY-LOAD LENS DELIVERY SYSTEM

K-Number: K132481 · 2013-12-27

ApplicantBausch & Lomb
Decision Date2013-12-27
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 & Lomb. It received FDA 510(k) clearance on 2013-12-27 under 510(k) number K132481. 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 2013-12-27. The listed applicant is Bausch & Lomb. The 510(k) number is K132481.

When did EASY-LOAD LENS DELIVERY SYSTEM receive FDA 510(k) clearance?

EASY-LOAD LENS DELIVERY SYSTEM received FDA 510(k) clearance on 2013-12-27, under 510(k) number K132481.

Who is the listed applicant for EASY-LOAD LENS DELIVERY SYSTEM?

The FDA 510(k) record lists Bausch & Lomb 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.

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Other records listing Bausch & Lomb 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.

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+K232084Stellaris Elite vision enhancement systemK132593CRYSTALSERT DELIVERY SYSTEMK123736CRYSTALSERT DELIVERY SYSTEMK061157SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENSK040913NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)

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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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