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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 a medical device manufactured by Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2016-11-16 under approval 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. It is manufactured by Alcon Laboratories, Inc.. The 510(k) number is K161288.

When was LenSX Laser System approved by the FDA?

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

What company makes LenSX Laser System?

LenSX Laser System is manufactured by Alcon Laboratories, Inc..

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 PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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Related Devices (Code: OOE)

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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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