K243055 is an FDA 510(k) clearance for the Pr?ime DermaFacial Collagen+, 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 review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K243055 FDA.gov |
| FDA Decision | Cleared 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. |