← Back to catalogue

CATALYS Precision Laser System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K210701

by AMO Manufacturing USA, LLC

Identifiers

510(k) Number
K210701 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, classified as a Class II device (product code OOE). It is designed for precise, laser-assisted procedures in ophthalmology, enabling minimally invasive corneal and cataract surgeries by delivering ultrafast laser pulses to perform incisions, capsulotomies, and lens fragmentation with high accuracy and reproducibility.

This system is intended for use in sterile operating environments by trained ophthalmic surgeons. It is a reusable medical device, regulated under FDA 510(k) clearance (K210701) and falls under the regulatory scope of 886.4390 for ophthalmic lasers. The device is not MRI-safe and requires proper storage and maintenance as specified by the manufacturer to ensure performance and sterility.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
AMO Manufacturing USA, LLC

Sources (1)

  • FDA 510(k) K210701 24 fields · synced Sep 18, 2026