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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 a medical device manufactured by EMA Aesthetics , Ltd.. It received FDA 510(k) clearance on 2025-04-01 under approval 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. It is manufactured by EMA Aesthetics , Ltd.. The 510(k) number is K243072.

When was Préime DermaFacial (MicroT) approved by the FDA?

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

What company makes Préime DermaFacial (MicroT)?

Préime DermaFacial (MicroT) is manufactured by EMA Aesthetics , Ltd..

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

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

Other Devices by EMA Aesthetics , Ltd.

K243055Préime DermaFacial Collagen+

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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.

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