Préime DermaFacial Collagen+— 510(k) K243055

Name: FDA 510(k) clearance K243055
Creator: U.S. Food and Drug Administration
Published: 2025-04-15

Substantially Equivalent

EMA Aesthetics , Ltd.

FDA 510(k) clearance K243055 for Préime DermaFacial Collagen+, Substantially Equivalent on 2025-04-15. Applicant: EMA Aesthetics , Ltd.. Device class: 2.

Clearance details

Applicant: EMA Aesthetics , Ltd.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2024-09-27
Decision date: 2025-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin 2, IE

Download summary PDF View on FDA.gov ↗

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