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FDA 510(k)

ALLY Adaptive Cataract Treatment System

K-Number: K220259 · 2022-06-09

ApplicantLensar, Inc.
Decision Date2022-06-09
Product CodeOOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ALLY Adaptive Cataract Treatment System is a medical device manufactured by Lensar, Inc.. It received FDA 510(k) clearance on 2022-06-09 under approval number K220259. 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 ALLY Adaptive Cataract Treatment System?

ALLY Adaptive Cataract Treatment System is a medical device that received FDA 510(k) clearance on 2022-06-09. It is manufactured by Lensar, Inc.. The 510(k) number is K220259.

When was ALLY Adaptive Cataract Treatment System approved by the FDA?

ALLY Adaptive Cataract Treatment System received FDA 510(k) clearance on 2022-06-09, under approval number K220259.

What company makes ALLY Adaptive Cataract Treatment System?

ALLY Adaptive Cataract Treatment System is manufactured by Lensar, Inc..

What is the FDA product code for ALLY Adaptive Cataract Treatment System?

The FDA product code for ALLY Adaptive Cataract Treatment System is OOE.

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Related PubMed Literature

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Other Devices by Lensar, Inc.

K171337LENSAR Laser System – fs 3D (LLS-fs 3D) K170576LENSAR Laser System - fs 3D (LLS-fs 3D) K182795LENSAR Laser System - fs 3D (LLS-fs 3D) K181430LENSAR Laser System - fs 3D (LLS-fs 3D) K173346LENSAR Laser System - fs 3D (LLS-fs 3D)

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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