Cleared Traditional

Catalys? Precision Laser System

K223838 · Amo Manufacturing USA, LLC · Ophthalmic

Apr 2023

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K223838 is an FDA 510(k) clearance for the Catalys? Precision Laser System, a Ophthalmic Femtosecond Laser (Class II — Special Controls, product code OOE), submitted by Amo Manufacturing USA, LLC (Milpitas, US). The FDA issued a Cleared decision on April 12, 2023, 111 days after receiving the submission on December 22, 2022. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K223838 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2022
Decision Date	April 12, 2023
Days to Decision	111 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF

Device Classification

Product Code	OOE — Ophthalmic Femtosecond Laser
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 886.4390
Definition	Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery.