Data / Medical devices / Spain / Unicskin SL
Unicskin SL: FDA-registered device maker in Madrid Madrid(Autonomous Community), Spain, 3 510(k) clearances
Unicskin SL is registered with the FDA (registration 3025309920) in Madrid Madrid(Autonomous Community), Spain. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 20, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3025309920
- Address
- Apolonio Morales 13 Oficina H, Madrid Madrid(Autonomous Community), Spain, 28036
- Owner or operator
- Unicskin Sl (10096320)
- Roles
- Exporter to the US, Foreign private label distributor
- First device listed
- September 3, 2026
- Registered through
- 2026
- Brand names listed
- UNICLED 5 CENTURION KOREAN MASK, UNICLED HELMET OMEGA 5, UNICLED NECK & CHIN MASK (MT-28), UNICLED NECK & CHIN MASK 5 (MT-28B)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Heat Source For Bleaching Teeth | EEG | 1 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Exporter to the US, Foreign private label distributor | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US, Foreign private label distributor | 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 |
|---|---|---|---|---|---|---|
| November 20, 2024 | K242363 | HIGHERDOSE Red Light Hat (HG-120K) | OAP | Substantially Equivalent | Shenzhen Kaiyan Medical Equipment Co., Ltd. | accessdata.fda.gov |
| April 10, 2024 | K240089 | Face Patches (MT-12MA, MT-12MC) | OHS | Substantially Equivalent | Shenzhen Kaiyan Medical Equipment Co., Ltd. | accessdata.fda.gov |
| December 20, 2022 | K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) | OHS | Substantially Equivalent | Light Tree Ventures Europe B.V. | accessdata.fda.gov |
Compare with other makers
- All makers of Heat Source For Bleaching Teeth
- All makers of Powered Laser Surgical Instrument
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Laser, Comb, Hair
Updated November 20, 2024. 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.