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FDA 510(k)

CRYSTALSERT DELIVERY SYSTEM

K-Number: K132593 · 2013-09-17

ApplicantBausch & Lomb
Decision Date2013-09-17
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CRYSTALSERT 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 2013-09-17 under 510(k) number K132593. 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 CRYSTALSERT DELIVERY SYSTEM?

CRYSTALSERT DELIVERY SYSTEM is a medical device that received FDA 510(k) clearance on 2013-09-17. The listed applicant is Bausch & Lomb. The 510(k) number is K132593.

When did CRYSTALSERT DELIVERY SYSTEM receive FDA 510(k) clearance?

CRYSTALSERT DELIVERY SYSTEM received FDA 510(k) clearance on 2013-09-17, under 510(k) number K132593.

Who is the listed applicant for CRYSTALSERT 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 CRYSTALSERT DELIVERY SYSTEM?

The FDA product code for CRYSTALSERT 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 systemK132481EASY-LOAD LENS DELIVERY SYSTEMK123736CRYSTALSERT DELIVERY SYSTEMK061157SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENSK040913NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)

View all 8 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.

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