Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Préime DermaFacial (MicroT)

K-Number: K243072 · 2025-04-01

ApplicantEMA Aesthetics , Ltd.
Decision Date2025-04-01
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Préime DermaFacial (MicroT) is the device name listed in this FDA 510(k) record. The listed applicant is EMA Aesthetics , Ltd.. It received FDA 510(k) clearance on 2025-04-01 under 510(k) number K243072. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Préime DermaFacial (MicroT)?

Préime DermaFacial (MicroT) is a medical device that received FDA 510(k) clearance on 2025-04-01. The listed applicant is EMA Aesthetics , Ltd.. The 510(k) number is K243072.

When did Préime DermaFacial (MicroT) receive FDA 510(k) clearance?

Préime DermaFacial (MicroT) received FDA 510(k) clearance on 2025-04-01, under 510(k) number K243072.

Who is the listed applicant for Préime DermaFacial (MicroT)?

The FDA 510(k) record lists EMA Aesthetics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Préime DermaFacial (MicroT)?

The FDA product code for Préime DermaFacial (MicroT) is NFO.

Other records listing EMA Aesthetics , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243055Préime DermaFacial Collagen+

Related Devices (Code: NFO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253932FACEGYM Pro Device (HD-109)Shenzhen Kaiyan Medical Equipment Co., Ltd.K260179VITA Multi-Function Head Brush (TB-2343F, TB-2442F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.K260895Ulike Clear Zero (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.K252621DeepSkin (DEP100)El Global Trade, Ltd.K252187Aura Glide (FC40)Aura Medical, LLCK252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)Shenzhen Siken 3D Technology Development Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑