KBL 7000 alpha hybridSun
KBL GmbH · Model KBL 6808 - 46h/4g 1616 cpi us (T) · UDI-DI 04260489020128
1
510(k) clearances
134
Adverse events (2 deaths)
6
Recalls
20
Facilities
Description
This device is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum intended for tanning of the human skin of an adult person.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-03-31 | J&T Health and Wellness LLC | In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit. |
| 2018-12-10 | ProSun International, LLC | ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output. |
| 2018-12-10 | ProSun International, LLC | ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output. |
| 2017-12-02 | ProSun International, LLC | The 30 minute maximum tanning time has been reduced to 20 minutes. |
| 2014-07-25 | JK Products & Services, Inc | The integrity of the wires inside main electrical chord become compromised from excessive flexing (during the door open/close process). |
| 2005-07-08 | JK Products & Services, Inc | The firm has tracked a systematic failure in the door cord on the Sun|Dash Radius 252 product line. In some instances when the door cord is installed with little or no slack outsi |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.