Préime DermaFacial (MicroT)— 510(k) K243072

Name: FDA 510(k) clearance K243072
Creator: U.S. Food and Drug Administration
Published: 2025-04-01

Substantially Equivalent

EMA Aesthetics , Ltd.

FDA 510(k) clearance K243072 for Préime DermaFacial (MicroT), Substantially Equivalent on 2025-04-01. Applicant: EMA Aesthetics , Ltd.. Device class: 2.

Clearance details

Applicant: EMA Aesthetics , Ltd.
Product code: Code NFO
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2024-09-27
Decision date: 2025-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin 2, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code NFO

view all

K253932 — FACEGYM Pro Device (HD-109)2026-07-23
K260179 — VITA Multi-Function Head Brush (TB-2343F, TB-2442F)2026-06-03
K260895 — Ulike Clear Zero (YC10 BU)2026-05-28
K252621 — DeepSkin (DEP100)2026-05-08
K252146 — Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)2025-12-23

More clearances from EMA Aesthetics , Ltd.

view all

K243055 — Préime DermaFacial Collagen+2025-04-15

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