Data / Medical devices / Netherlands / Ultrasun
Ultrasun: FDA-registered device maker in HENGELO Overijssel, Netherlands, 3 510(k) clearances
Ultrasun is registered with the FDA (registration 9680413) in HENGELO Overijssel, Netherlands. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 10, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680413
- FEI number
- 3004531930
- Address
- Granaatstraat 6, HENGELO Overijssel, Netherlands, 7554 TR
- Owner or operator
- Ultrasun International B.V. (9008844)
- Roles
- Manufacturer
- First device listed
- December 28, 2017
- Registered through
- 2026
- Brand names listed
- DR MUELLER COLLASHOWER 48 WITH VIBRAPLATE, E6, Q10, Q14, Q18, Q22, Q6-0, Q6-2 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Booth, Sun Tan | LEJ | 2 | Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer | accessdata.fda.gov |
| Exerciser, Powered | BXB | 1 | Manufacturer | accessdata.fda.gov |
| Light, Ultraviolet, Dermatological | FTC | 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 |
|---|---|---|---|---|---|---|
| December 10, 2021 | K210004 | i8 Tanning Booth | FTC | Substantially Equivalent | Ultrasun International B.V. | accessdata.fda.gov |
| December 17, 2015 | K151370 | UV Lamps for Indoor Tanning Devices | LEJ | Substantially Equivalent | Light Sources, Inc. | accessdata.fda.gov |
| March 28, 1986 | K860931 | ULTRASUN 3000 AND 5000 SUNTANNING UNIT | FTC | Substantially Equivalent | Medical Device Consultants, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Booth, Sun Tan
- All makers of Disinfectant, Medical Devices
- All makers of Light, Ultraviolet, Dermatological
- All makers of Exerciser, Powered
Updated December 10, 2021. 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.