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FDA 510(k)

Catalys Precision Laser System

K-Number: K182083 · 2018-11-09

ApplicantAmo Manufacturing USA, LLC
Decision Date2018-11-09
Product CodeOOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Catalys Precision Laser System is a medical device manufactured by Amo Manufacturing USA, LLC. It received FDA 510(k) clearance on 2018-11-09 under approval number K182083. 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 Catalys Precision Laser System?

Catalys Precision Laser System is a medical device that received FDA 510(k) clearance on 2018-11-09. It is manufactured by Amo Manufacturing USA, LLC. The 510(k) number is K182083.

When was Catalys Precision Laser System approved by the FDA?

Catalys Precision Laser System received FDA 510(k) clearance on 2018-11-09, under approval number K182083.

What company makes Catalys Precision Laser System?

Catalys Precision Laser System is manufactured by Amo Manufacturing USA, LLC.

What is the FDA product code for Catalys Precision Laser System?

The FDA product code for Catalys Precision Laser System is OOE.

Related Clinical Trials

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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 Amo Manufacturing USA, LLC

K172002Catalys Precision Laser System K210701CATALYS Precision Laser System K220516CATALYS Precision Laser system K223838Catalys™ Precision Laser System PMA P930016Excimer laser system PMA P990010Excimer laser system

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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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