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FDA 510(k)

LenSx Laser System (8065000944)

K-Number: K252682 · 2025-09-24

ApplicantAlcon Laboratories, Inc.
Decision Date2025-09-24
Product CodeOOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LenSx Laser System (8065000944) is a medical device manufactured by Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2025-09-24 under approval number K252682. 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 (8065000944)?

LenSx Laser System (8065000944) is a medical device that received FDA 510(k) clearance on 2025-09-24. It is manufactured by Alcon Laboratories, Inc.. The 510(k) number is K252682.

When was LenSx Laser System (8065000944) approved by the FDA?

LenSx Laser System (8065000944) received FDA 510(k) clearance on 2025-09-24, under approval number K252682.

What company makes LenSx Laser System (8065000944)?

LenSx Laser System (8065000944) is manufactured by Alcon Laboratories, Inc..

What is the FDA product code for LenSx Laser System (8065000944)?

The FDA product code for LenSx Laser System (8065000944) 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)

Other Devices by Alcon Laboratories, Inc.

K161391DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives K161288LenSX Laser System K162597Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc K162596AIR OPTIX COLORS K160609AIR OPTIX plus HydraGlyde, AIR OPTIX plus HydraGlyde for Astigmatism, AIR OPTIX plus HydraGlyde Multifocal, AIR OPTIX plus HydraGlyde Multifocal Toric K153642DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal

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Related Devices (Code: OOE)

K161288LenSX Laser SystemAlcon Laboratories, Inc. K161455Catalys Precision Laser SystemOptimedica Corporation K171014VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH K172002Catalys Precision Laser SystemAmo Manufacturing USA, LLC K171337LENSAR Laser System – fs 3D (LLS-fs 3D)Lensar, Inc. K170322Catalys Precision Laser SystemAbbott Medical Optics, 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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