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Préime DermaFacial Collagen+

by EMA Aesthetics, Ltd.

Préime DermaFacial Collagen+ is a multi-modality skin surface treatment system (FDA Class II; FDA product code PBX, Massager, Vacuum, Radio Frequency Induced Heat) made by EMA Aesthetics, Ltd., cleared under FDA 510(k) K243055 on 15 Apr 2025 and listed in FDA GUDID since 7 Aug 2025 (UDI-DI 05391540830857), 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) K243055

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 Number05391540830857 UDI-DI Date7 Aug 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243055 Date15 Apr 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243055 decided 15 Apr 2025 Active
  • FDA GUDID UDI-DI 05391540830857 listed 7 Aug 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243055
  2. Listed FDA GUDID 05391540830857

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  • Withdrawn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
Collagen+
Primary DI / UDI-DI
05391540830857
510(k) Number
FDA product code
PBX
GMDN term
Multi-modality skin surface treatment system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multi-modality skin surface treatment system

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)