Data / Medical devices / Ireland / Ema Aesthetic Ltd
Ema Aesthetic Ltd: FDA-registered device maker in Dublin Dublin(City), Ireland, 2 510(k) clearances
Ema Aesthetic Ltd is registered with the FDA (registration 3021177911) in Dublin Dublin(City), Ireland. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021177911
- Address
- Waterloo Exchange, Waterloo Road, Dublin Dublin(City), Ireland, D04 E5W7
- Owner or operator
- EMA Aesthetic Limited (10083797)
- Roles
- Manufacturer
- First device listed
- December 20, 2021
- Registered through
- 2026
- Brand names listed
- Preime DermaFacial - AquaB, Preime DermaFacial - Collagen+, Preime DermaFacial - MicroT, Preime DermaFacial - VibroX
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 15, 2025 | K243055 | Préime DermaFacial Collagen+ | PBX | Substantially Equivalent | EMA Aesthetics , Ltd. | accessdata.fda.gov |
| April 1, 2025 | K243072 | Préime DermaFacial (MicroT) | NFO | Substantially Equivalent | EMA Aesthetics , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Brush, Dermabrasion, Powered
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- All makers of Massager, Therapeutic, Electric
Updated April 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.