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FDA 510(k)

Catalys Precision Laser System

K-Number: K161455 · 2016-09-20

ApplicantOptimedica Corporation
Decision Date2016-09-20
Product CodeOOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Catalys Precision Laser System is a medical device manufactured by Optimedica Corporation. It received FDA 510(k) clearance on 2016-09-20 under approval number K161455. 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 2016-09-20. It is manufactured by Optimedica Corporation. The 510(k) number is K161455.

When was Catalys Precision Laser System approved by the FDA?

Catalys Precision Laser System received FDA 510(k) clearance on 2016-09-20, under approval number K161455.

What company makes Catalys Precision Laser System?

Catalys Precision Laser System is manufactured by Optimedica Corporation.

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)

Related Devices (Code: OOE)

K161288LenSX Laser SystemAlcon Laboratories, Inc. 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. K170576LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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