Data / Medical devices / Germany / KBL GmbH
KBL GmbH: FDA-registered device maker in Dernbach Rhineland-Palatinate, Germany, 2 510(k) clearances
KBL GmbH is registered with the FDA (registration 3006116732) in Dernbach Rhineland-Palatinate, Germany. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 28, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006116732
- Address
- Ringstrasse 24-26, Dernbach Rhineland-Palatinate, Germany, 56307
- Owner or operator
- KBL GmbH (10030591)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- November 11, 2016
- Registered through
- 2026
- Brand names listed
- A5R, CL-100, K5R, KBL 4800 alpha, KBL 4800 alpha extraSun+, KBL 5600 alpha, KBL 5600 alpha extraSun+, KBL 6700 alpha and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Booth, Sun Tan | LEJ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Exerciser, Powered | BXB | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Fat Reducing Low Level Laser | OLI | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| October 28, 2019 | K191881 | KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun | LEJ | Substantially Equivalent | Kbl GmbH | accessdata.fda.gov |
| September 15, 2016 | K151962 | KBL Sunlamp Products (= Device Bundling name) | LEJ | Substantially Equivalent | Kbl AG | accessdata.fda.gov |
Compare with other makers
- All makers of Fat Reducing Low Level Laser
- All makers of Booth, Sun Tan
- All makers of Exerciser, Powered
Updated October 28, 2019. 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.