K243055 is an FDA 510(k) clearance for the Préime DermaFacial Collagen+. This device is classified as a Massager, Vacuum, Radio Frequency Induced Heat (Class II - Special Controls, product code PBX).
Submitted by EMA Aesthetics , Ltd. (Dublin 2, IE). The FDA issued a Cleared decision on April 15, 2025, 200 days after receiving the submission on September 27, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite..
| 510(k) Number | K243055 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2024 |
| Decision Date | April 15, 2025 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | PBX - Massager, Vacuum, Radio Frequency Induced Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite. |