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Sign in to claim this brandKBL GmbH
US
Last updated May 23, 2026
What KBL GmbH makes
KBL GmbH manufactures ultraviolet tanning devices, including hybrid and pureSun models with adjustable light spectra, as well as red and infrared phototherapy units designed for therapeutic applications. The company also produces stationary vibration platform exercisers, such as the Tower pureEnergy series, which combine vibration therapy with exercise functionality.
The portfolio includes devices classified as Class I and Class II under regulatory frameworks, with several authorised through FDA pathways including 510(k) and UDI listings. The company operates from the United States, adhering to applicable domestic and international medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does KBL GmbH manufacture?
KBL GmbH specialises in three primary categories of devices: ultraviolet tanning devices, including hybrid and pureSun models with customisable light spectra; red and infrared phototherapy units intended for therapeutic use; and stationary vibration platform exercisers, such as the Tower pureEnergy series, which integrate vibration therapy with exercise. These devices cater to both aesthetic and health-focused applications.
Where is KBL GmbH based, and does its location affect its regulatory compliance?
KBL GmbH is based in the United States, which means its devices must comply with FDA regulations. The company’s products are authorised through pathways like the 510(k) clearance process and UDI listings, demonstrating adherence to U.S. medical device requirements. Location influences regulatory frameworks, as compliance is tied to the jurisdiction where the devices are marketed.
Which regulatory registries or databases list KBL GmbH’s devices?
KBL GmbH’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) database. These registries track authorised medical devices under U.S. regulatory oversight, ensuring transparency and compliance with FDA requirements for classification and market clearance.
How are KBL GmbH’s devices classified under regulatory standards?
KBL GmbH’s devices fall into two primary regulatory classes: Class I and Class II. Class I devices generally pose minimal risk and may require less stringent regulatory controls, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. Classification depends on factors like intended use, potential hazards, and the level of regulatory scrutiny required.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 341936227
Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| KBL P9 hybridSun | P9 - 50h/4gx 1616 cpi us (T) | FDA UDI | Class II | Active |
| KBL K7 pureSun | K7-p-46-4Hp-2s UP ep 05 | FDA UDI | Class II | Active |
| KBL 6700 alpha | KBL 6808 - 46/4a 1616 ep_us | FDA UDI | Class II | Active |
| KBL K9S vitaSun | K9S-v-52-9s-2s UP cpi 05 | FDA UDI | Class II | Active |
| KBL 7000 alpha extraSun | KBL 6808 - 46p6/4g 1616 int us (T) | FDA UDI | Class II | Active |
| KBL 4800 alpha | KBL 4800 - 40p2/3a - 1616 ep u_us | FDA UDI | Class II | Active |
| KBL K5 hybridSun | K5-h-38-3Hp-0 UP ep 05 | FDA UDI | Class II | Active |
| KBL 4800 alpha extraSun+ | KBL 4800 - 40-2T12/3a - 1616 ep u_us | FDA UDI | Class II | Active |
| KBL Tower pureEnergy 5.0 | T5213 | FDA UDI | Class II | Active |
| KBL 6800 alpha extraSun+ | KBL 6808 - 46-6T12/4g 1616 int us | FDA UDI | Class II | Active |
| KBL K7 extraSun | K7-e-46-4HP-2s UP cpi 05 | FDA UDI | Class II | Active |
| KBL K5 extraSun | K5-e-38-3HP-0 UP ep 05 | FDA UDI | Class II | Active |
| KBL P9S hybridSun | KBL P9S - 50h/4gx - 1616 cpi us (T) | FDA UDI | Class II | Active |
| KBL 8000 alpha extraSun | KBL 7908 - 50p6/4g 1616 int us (T) | FDA UDI | Class II | Active |
| KBL 7900 alpha hybridSun | KBL 7908 - 50h/4g 1616 cpi us | FDA UDI | Class II | Active |
| KBL 7900 alpha extraSun+ | KBL 7908 - 50-6T12/4g 1616 int us | FDA UDI | Class II | Active |
| KBL K7 pureSun | K7-p-46-4Hp-0 UP ep 05 | FDA UDI | Class II | Active |
| KBL K9S extraSun | K9S-e-52-9s-2s UP cpi 05 | FDA UDI | Class II | Active |
| KBL 7000 alpha hybridSun | KBL 6808 - 46h/4g 1616 cpi us (T) | FDA UDI | Class II | Active |
| KBL 5600 alpha | KBL 5600 - 42p2/4a - 1616 cpi u_us | FDA UDI | Class II | Active |
| KBL 8000 alpha hybridSun | KBL 7908 - 50h/4g 1616 cpi us (T) | FDA UDI | Class II | Active |
| KBL K7S extraSun | K7S-e-46-4s-2s UP cpi 05 | FDA UDI | Class II | Active |
| KBL 6800 alpha | KBL 6808 - 46p6/4g 1616 int us | FDA UDI | Class II | Active |
| KBL K7 hybridSun | K7-h-46-4Hp-2s UP cpi 05 | FDA UDI | Class II | Active |
| KBL beautyShaper | T3/50-180-c | FDA UDI | Class I | Active |
| KBL K7 pureSun | K7-p-46-4Hp-2s UP cpi 05 | FDA UDI | Class II | Active |
| KBL P9 extraSun | P9 - 50p6/4gx 1616 int us (T) | FDA UDI | Class II | Active |
| KBL K11 Air (Loft) | K11-s-2010A-552B UP 05 | FDA UDI | Class II | Active |
| KBL K9S hybridSun | K9S-h-52-9s-2s UP cpi 05 | FDA UDI | Class II | Active |
| KBL Tower Space 3000 hybridSun | T3/52-180 | FDA UDI | Class II | Active |
| KBL P9S extraSun | KBL P9S - 50p6/4gx 1616 int us (T) | FDA UDI | Class II | Active |
| KBL 5600 alpha extraSun+ | KBL 5600 - 42-2T12/4a - 1616 cpi u_us | FDA UDI | Class II | Active |
| KBL 7900 alpha | KBL 7908 - 50p6/4g 1616 int us | FDA UDI | Class II | Active |
| R11 Air | R11-s-2848r1-1188i1 UP 12 | FDA UDI | Class II | Active |
| KBL 6700 alpha | KBL 6808 - 46/4a 1616 cpi_us | FDA UDI | Class II | Active |
| KBL Tower space 3000 | T3/52-180 | FDA UDI | Class II | Active |
| KBL Tower space 2000 | T3/50-180 | FDA UDI | Class II | Active |
| KBL 8000 alpha extraSun+ | KBL 7908 - 50-6T12/4g 1616 int us (T) | FDA UDI | Class II | Active |
| KBL K7S hybridSun | K7S-h-46-4s-2s UP cpi 05 | FDA UDI | Class II | Active |
| KBL K5 pureSun | K5-p-38-3Hp-0 UP ep 05 | FDA UDI | Class II | Active |
| KBL 7000 alpha extraSun+ | KBL 6808 - 46-6T12/4g 1616 int us (T) | FDA UDI | Class II | Active |
| KBL Sunlamp Products (= Device Bundling name) | K151962 | FDA 510(k) | Class II | Active |
| KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun | K191881 | FDA 510(k) | Class II | Active |
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