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Préime DermaFacial (MicroT)

by EMA Aesthetics, Ltd.

510(k) K243072

Préime DermaFacial (MicroT) is a medical device (FDA Class II; FDA product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes) made by EMA Aesthetics, Ltd., cleared under FDA 510(k) K243072 on 1 Apr 2025, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK243072 Date1 Apr 2025ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NFO
FDA applicant
EMA Aesthetics , Ltd.
Device class
Class II
Regulation
21 CFR Part 882.5890
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Devices cleared under K243072

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K243072
UDI-DISize and differences
Préime DermaFacial Console
EMA Aesthetics, Ltd.
Console05391540830871 —On the market
Préime DermaFacial MicroT
EMA Aesthetics, Ltd.
MicroT05391540830840 —On the market

Similar devices

Other devices filed under FDA product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Other devices from EMA Aesthetics, Ltd.

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