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Préime DermaFacial Console

by EMA Aesthetics, Ltd.

Préime DermaFacial Console is a multi-modality skin surface treatment system (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 and listed in FDA GUDID since 15 Sep 2025 (UDI-DI 05391540830871), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K243072

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05391540830871 UDI-DI Date15 Sep 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243072 Date1 Apr 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243072 decided 1 Apr 2025 Active
  • FDA GUDID UDI-DI 05391540830871 listed 15 Sep 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243072
  2. Listed FDA GUDID 05391540830871

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Préime DermaFacial
Generic name
Multi-modality skin surface treatment system
Model / reference
Console
Primary DI / UDI-DI
05391540830871
510(k) Number
FDA product code
NFO
GMDN term
Multi-modality skin surface treatment system
Device class
Class II
Regulation number
882.5890
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multi-modality skin surface treatment system

Cleared under the same submission (K243072)

Similar devices in this category

Other devices filed under Multi-modality skin surface treatment system.

Other devices from EMA Aesthetics, Ltd.

See all devices from EMA Aesthetics, Ltd. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)