Ultravision Visual Field Clearing System— 510(k) K200035

Name: FDA 510(k) clearance K200035
Creator: U.S. Food and Drug Administration
Published: 2020-05-04

Substantially Equivalent

Alesi Surgical, Ltd.

FDA 510(k) clearance K200035 for Ultravision Visual Field Clearing System, Substantially Equivalent on 2020-05-04. Applicant: Alesi Surgical, Ltd.. Device class: 2.

Clearance details

Applicant: Alesi Surgical, Ltd.
Product code: Code PQM
Device class: Class 2
Regulation: 21 CFR 878.5050
Advisory panel: General, Plastic Surgery
Date received: 2020-01-08
Decision date: 2020-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cardiff, GB

Download summary PDF View on FDA.gov ↗

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