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FDA 510(k)

Lenstec LC Injection system

K-Number: K161776 · 2016-11-29

ApplicantLenstec, Inc.
Decision Date2016-11-29
Product CodeMSS
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Lenstec LC Injection system is a medical device manufactured by Lenstec, Inc.. It received FDA 510(k) clearance on 2016-11-29 under approval number K161776. 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 Lenstec LC Injection system?

Lenstec LC Injection system is a medical device that received FDA 510(k) clearance on 2016-11-29. It is manufactured by Lenstec, Inc.. The 510(k) number is K161776.

When was Lenstec LC Injection system approved by the FDA?

Lenstec LC Injection system received FDA 510(k) clearance on 2016-11-29, under approval number K161776.

What company makes Lenstec LC Injection system?

Lenstec LC Injection system is manufactured by Lenstec, Inc..

What is the FDA product code for Lenstec LC Injection system?

The FDA product code for Lenstec LC Injection system is MSS.

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Other Devices by Lenstec, Inc.

PMA P090022intraocular lens PMA P200020Lens, multifocal intraocular

Related Devices (Code: MSS)

K161012Easy-Load Lens Delivery SystemBausch and Lomb, Inc., K172228pioli IOL Delivery SystemAst Products, Inc. K173480Crystalsert Lens Delivery SystemBausch & Lomb, Inc. K172375MicroSTAAR Injector System CartridgesSTAAR Surgical Company K181401RxSight Insertion DeviceRxsight, Inc. K192005Bausch + Lomb PreVue Inserter for enVista PreloadedBausch & Lomb, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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