K243055
- 510(k) number
- K243055
- Device name
- Préime DermaFacial Collagen+
- Applicant
- EMA Aesthetics , Ltd. IE
- Product code
- PBX — Massager, Vacuum, Radio Frequency Induced Heat
- Decision date
- 2025-04-15
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K243055
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.