Préime DermaFacial MicroT
Préime DermaFacial MicroT 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 7 Aug 2025 (UDI-DI 05391540830840), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05391540830840 | Date7 Aug 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK243072 | Date1 Apr 2025 | StatusActive |
Official records
- AccessGUDID record 05391540830840
- FDA 510(k) database K243072
Across registries
- FDA 510(k) K243072 decided 1 Apr 2025 Active
- FDA GUDID UDI-DI 05391540830840 listed 7 Aug 2025 Listed
Timeline
- Cleared FDA 510(k) K243072
- Listed FDA GUDID 05391540830840
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Préime DermaFacial
- Generic name
- Multi-modality skin surface treatment system
- Model / reference
- MicroT
- Primary DI / UDI-DI
- 05391540830840
- 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
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