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FDA 510(k)

Crystalsert Lens Delivery System

K-Number: K173480 · 2017-12-11

ApplicantBausch & Lomb, Inc.
Decision Date2017-12-11
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Crystalsert Lens Delivery System is a medical device manufactured by Bausch & Lomb, Inc.. It received FDA 510(k) clearance on 2017-12-11 under approval number K173480. 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 Lens Delivery System?

Crystalsert Lens Delivery System is a medical device that received FDA 510(k) clearance on 2017-12-11. It is manufactured by Bausch & Lomb, Inc.. The 510(k) number is K173480.

When was Crystalsert Lens Delivery System approved by the FDA?

Crystalsert Lens Delivery System received FDA 510(k) clearance on 2017-12-11, under approval number K173480.

What company makes Crystalsert Lens Delivery System?

Crystalsert Lens Delivery System is manufactured by Bausch & Lomb, Inc..

What is the FDA product code for Crystalsert Lens Delivery System?

The FDA product code for Crystalsert Lens Delivery System is MSS.

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Related Devices (Code: MSS)

K161776Lenstec LC Injection systemLenstec, Inc. K161012Easy-Load Lens Delivery SystemBausch and Lomb, Inc., K172228pioli IOL Delivery SystemAst Products, Inc. K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company K181401RxSight Insertion DeviceRxsight, Inc. K192005Bausch + Lomb PreVue Inserter for enVista PreloadedBausch & Lomb, 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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