Data / Medical devices / United Kingdom / Bleckmann UK
Bleckmann UK: FDA-registered device maker in SN5 5FZ Wiltshire, United Kingdom, 1 510(k) clearance
Bleckmann UK is registered with the FDA (registration 3024892917) in SN5 5FZ Wiltshire, United Kingdom. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 18, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024892917
- Address
- Unit 1 & 2 Trinity Park Hillmead Drive, SN5 5FZ Wiltshire, United Kingdom, Swindon
- Owner or operator
- Logistics Investmen 1 BV (10086306)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- October 28, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Exporter to the US, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 18, 2022 | K210823 | LYMA Laser | OHS | Substantially Equivalent | Lyma Life , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Light Based Over The Counter Wrinkle Reduction
Updated March 18, 2022. 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.