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Catalys Precision Laser System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182083

by AMO Manufacturing USA, LLC

Identifiers

510(k) Number
K182083 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 corneal and cataract surgeries. It employs ultrafast laser pulses to perform intricate tissue cuts and incisions, enabling minimally invasive procedures such as corneal refractive surgery and cataract lens fragmentation.

This device is supplied as a reusable medical instrument, intended for use in sterile operating environments by trained ophthalmic professionals. It is classified as a Class 2 device under FDA regulations (product code OOE) and has received FDA 510(k) clearance through the Traditional pathway. No specific MRI safety or sterility certification beyond standard surgical instrument protocols is noted in the data.

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 (K223838) — FDA 510(k) | Innolitics

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) K182083 24 fields · synced Sep 18, 2026