Data / Medical devices / Spain / High Technology Products, Slu
High Technology Products, Slu: FDA-registered device maker in Esplugues de Llobregat Barcelona, Spain, 5 510(k) clearances
High Technology Products, Slu is registered with the FDA (registration 3016413636) in Esplugues de Llobregat Barcelona, Spain. It lists 4 device types. The FDA files 5 510(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
- 3016413636
- Address
- Carrer del Gall, 22, Esplugues de Llobregat Barcelona, Spain, 08950
- Owner or operator
- High Technology Products, SLU (10061761)
- Roles
- Complaint file establishment, Exporter to the US, Specification developer
- First device listed
- November 18, 2019
- Registered through
- 2026
- Brand names listed
- Elysion Pro, Preime DermaFacial - MicroT, Preime DermaFacial - VibroX, Preime DermaFacial Collagen+, Primelase
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Exporter to the US | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 2 | Exporter to the US | 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 |
| December 17, 2020 | K201594 | Primelase Excellence | GEX | Substantially Equivalent | High Technology Products S.L.U | accessdata.fda.gov |
| March 12, 2020 | K193367 | elysion-pro | GEX | Substantially Equivalent | High Technology Products S.L.U | accessdata.fda.gov |
| August 2, 2019 | K191321 | Primelase Excellence | GEX | Substantially Equivalent | High Technology Products S.L.U | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- All makers of Massager, Therapeutic, Electric
- All makers of Powered Laser Surgical Instrument
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
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.