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Catalys Precision Laser System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172002

by AMO Manufacturing USA, LLC

Identifiers

510(k) Number
K172002 FDA 510(k)
FDA Product Code
OOE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.4390 FDA 510(k)
Regulation Number
886.4390 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Catalys Precision Laser System is an Ophthalmic Femtosecond Laser, designed for precise laser-assisted procedures in eye surgery. It employs femtosecond laser technology to perform intricate cuts and incisions in corneal and cataract surgeries, enhancing surgical precision and reducing reliance on manual techniques.

This device is intended for use in ophthalmic settings and is supplied as a reusable medical instrument. It has received FDA 510(k) clearance under the Traditional pathway and is classified as a Class 2 device (Product Code: OOE). The system adheres to regulatory standards for ophthalmic laser devices, ensuring compliance with safety and performance requirements for surgical applications.

Frequently asked questions

What types of eye surgeries can the Catalys Precision Laser System be used for, and how does it improve surgical outcomes?

The Catalys Precision Laser System is designed for laser-assisted procedures in corneal and cataract surgeries, such as creating precise corneal incisions or capsulotomies. By employing femtosecond laser technology, it enhances surgical precision by automating intricate cuts, reducing reliance on manual techniques, and minimizing potential human error. This leads to more consistent and controlled outcomes, improving patient safety and recovery.

Is the Catalys Precision Laser System intended for single-use or reusable applications, and what does this mean for maintenance and cost?

The Catalys Precision Laser System is supplied as a reusable medical instrument, meaning it is built for repeated use in clinical settings after proper cleaning, sterilization, and maintenance. This design approach can reduce per-procedure costs over time compared to single-use devices, though it requires adherence to strict infection control protocols and regular servicing to ensure performance and safety.

How is the device regulated, and what does its classification as a Class 2 device imply for its use in ophthalmic settings?

The Catalys Precision Laser System has received FDA 510(k) clearance under the Traditional pathway, confirming it meets regulatory standards for ophthalmic laser devices. As a Class 2 device, it is subject to general controls and special controls specific to its category (Product Code: OOE), including performance testing and labeling requirements. This classification ensures it undergoes rigorous evaluation for safety and effectiveness in controlled surgical environments.

What should clinicians consider when storing or preparing the Catalys Precision Laser System for use in procedures?

Since the Catalys Precision Laser System is reusable, proper storage and maintenance are critical. Clinicians should follow manufacturer guidelines for cleaning, sterilization (e.g., autoclave or chemical sterilization), and calibration to ensure optimal performance and longevity. The device should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to prevent damage or contamination before use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K182083 - Catalys Precision Laser System | FDA 510 (k), Catalys Precision Laser System (K223838) — FDA 510 (k) | Innolitics, Amo Manufacturing USA, LLC FDA 510 (k) Products 2023, Catalys Precision Laser System 510(k) K182083 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
AMO Manufacturing USA, LLC

Sources (1)

  • FDA 510(k) K172002 24 fields · synced Sep 18, 2026