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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 the device name listed in this FDA 510(k) record. The listed applicant is Amo Manufacturing USA, LLC. It received FDA 510(k) clearance on 2018-11-09 under 510(k) 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. The listed applicant is Amo Manufacturing USA, LLC. The 510(k) number is K182083.

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

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

Who is the listed applicant for Catalys Precision Laser System?

The FDA 510(k) record lists Amo Manufacturing USA, LLC 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.

Other records listing Amo Manufacturing USA, LLC as applicant

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.

PMA P930016Excimer laser systemK223838Catalys™ Precision Laser SystemK220516CATALYS Precision Laser systemK210701CATALYS Precision Laser SystemPMA P990010Excimer laser systemPMA P910062Excimer laser system

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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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