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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 the device name listed in this FDA 510(k) record. The listed applicant is Optimedica Corporation. It received FDA 510(k) clearance on 2016-09-20 under 510(k) 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. The listed applicant is Optimedica Corporation. The 510(k) number is K161455.

When did Catalys Precision Laser System receive FDA 510(k) clearance?

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

Who is the listed applicant for Catalys Precision Laser System?

The FDA 510(k) record lists Optimedica Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: OOE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc.K223838Catalys™ Precision Laser SystemAmo Manufacturing USA, LLCK220259ALLY Adaptive Cataract Treatment SystemLensar, Inc.K220516CATALYS Precision Laser systemAmo Manufacturing USA, LLC

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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