Pollogen STOP U Model UXV Device— 510(k) K220322

Name: FDA 510(k) clearance K220322
Creator: U.S. Food and Drug Administration
Published: 2023-05-04

Substantially Equivalent

Pollogen, Ltd.

FDA 510(k) clearance K220322 for Pollogen STOP U Model UXV Device, Substantially Equivalent on 2023-05-04. Applicant: Pollogen, Ltd.. Device class: 2.

Clearance details

Applicant: Pollogen, Ltd.
Product code: Code PAY
Device class: Class 2
Regulation: 21 CFR 878.4420
Advisory panel: General, Plastic Surgery
Date received: 2022-02-03
Decision date: 2023-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

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