Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Catalys Precision Laser System

K-Number: K170322 · 2017-05-19

ApplicantAbbott Medical Optics, Inc.
Decision Date2017-05-19
Product CodeOOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Catalys Precision Laser System is a medical device manufactured by Abbott Medical Optics, Inc.. It received FDA 510(k) clearance on 2017-05-19 under approval number K170322. 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 2017-05-19. It is manufactured by Abbott Medical Optics, Inc.. The 510(k) number is K170322.

When was Catalys Precision Laser System approved by the FDA?

Catalys Precision Laser System received FDA 510(k) clearance on 2017-05-19, under approval number K170322.

What company makes Catalys Precision Laser System?

Catalys Precision Laser System is manufactured by Abbott Medical Optics, Inc..

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

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07607496 MacuTherm Performance Study in Patients With iAMD NOT_YET_RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING

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 Abbott Medical Optics, Inc.

K160236Dual Pump Pack

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. K170576LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, 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.

↑