Catalys Precision Laser System— 510(k) K223838

Name: FDA 510(k) clearance K223838
Creator: U.S. Food and Drug Administration
Published: 2023-04-12

Substantially Equivalent

Amo Manufacturing USA, LLC

FDA 510(k) clearance K223838 for Catalys Precision Laser System, Substantially Equivalent on 2023-04-12. Applicant: Amo Manufacturing USA, LLC. Device class: 2.

Clearance details

Applicant: Amo Manufacturing USA, LLC
Product code: Code OOE
Device class: Class 2
Regulation: 21 CFR 886.4390
Advisory panel: Ophthalmic
Date received: 2022-12-22
Decision date: 2023-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OOE

view all

K252682 — LenSx Laser System (8065000944)2025-09-24
K243896 — LenSx Laser System (8065998162)2025-04-28
K223566 — ELITA Femtosecond Laser System, ELITA Patient Interface2023-04-14
K220259 — ALLY Adaptive Cataract Treatment System2022-06-09
K220516 — CATALYS Precision Laser system2022-05-17

More clearances from Amo Manufacturing USA, LLC

view all

K210701 — CATALYS Precision Laser System2021-04-07
K182083 — Catalys Precision Laser System2018-11-09
K172002 — Catalys Precision Laser System2017-08-25
K141852 — IFS ADVANCED FEMTOSECOND LASER SYSTEM2015-01-06

Adverse events under product code OOE

product code OOE

Injury: 1,104
Malfunction: 864
Total: 1,968

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.