Catalys Precision Laser System— 510(k) K161455

Name: FDA 510(k) clearance K161455
Creator: U.S. Food and Drug Administration
Published: 2016-09-20

Substantially Equivalent

Optimedica Corporation

FDA 510(k) clearance K161455 for Catalys Precision Laser System, Substantially Equivalent on 2016-09-20. Applicant: Optimedica Corporation. Device class: 2.

Clearance details

Applicant: Optimedica Corporation
Product code: Code OOE
Device class: Class 2
Regulation: 21 CFR 886.4390
Advisory panel: Ophthalmic
Date received: 2016-05-26
Decision date: 2016-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OOE

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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
K223838 — Catalys Precision Laser System2023-04-12
K220259 — ALLY Adaptive Cataract Treatment System2022-06-09

More clearances from Optimedica Corporation

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K141079 — OPTIMEDICA CATALYS PRECISION LASER SYSTEM2014-09-11
K121091 — CATALYS PRECISION LASER SYSTEM2012-08-28
K113479 — OPTIMEDICA CATALYS PRECISION LASER SYSTEM2011-12-21
K100019 — PASCAL STREAMLINE PHOTOCOAGULATOR2010-05-04
K091666 — PASCAL PHOTOCOAGULATOR, PASCAL-US2009-07-15

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.