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FDA 510(k)

LenSX Laser System

K-Number: K161288 · 2016-11-16

ApplicantAlcon Laboratories, Inc.
Decision Date2016-11-16
Product CodeOOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LenSX Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2016-11-16 under 510(k) number K161288. The device is classified under product code OOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LenSX Laser System?

LenSX Laser System is a medical device that received FDA 510(k) clearance on 2016-11-16. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K161288.

When did LenSX Laser System receive FDA 510(k) clearance?

LenSX Laser System received FDA 510(k) clearance on 2016-11-16, under 510(k) number K161288.

Who is the listed applicant for LenSX Laser System?

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

What is the FDA product code for LenSX Laser System?

The FDA product code for LenSX Laser System is OOE.

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Related Devices (Code: OOE)

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K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc.K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLCK220259ALLY Adaptive Cataract Treatment SystemLensar, Inc.K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC

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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