Panels › General, Plastic Surgery › Product code LEJ · Class 2
Booth, Sun Tan
Regulation 878.4635
0510(k)s in 12 months (81 all time)
0recalls in 12 months (6 all time)
3recalls that name a 510(k)
Top companies in LEJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Jk Holding GmbH | 6 | 0 |
| Cosmedico Light, Inc. | 4 | 0 |
| Prosun International, LLC | 1 | 3 |
| Eurocut, Ltd. | 2 | 0 |
| Health Systems Intl., Inc. | 2 | 0 |
| JK Products & Services, Inc | 0 | 2 |
| Kbl AG | 2 | 0 |
| Kohler | 2 | 0 |
| Rami-Tan | 2 | 0 |
| Sportarredo Group S.C. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2023 | J&T Health and Wellness LLC ProSun International Luxura Vegaz, Model 52X; Ultraviolet Tanning Device Open, Classified |
LEJ | None listed |
| Dec 10, 2018 | ProSun International, LLC ProSun V3 42 Xlc(160w)(10 minutes) tanning bed, Model 500. Labeled as the following: PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE (TMAX READY), PROSUN V3 42 HIGH INTENSIVE (160W) PEARL WHITE, PROS Terminated |
LEJ | K181455 |
| Dec 10, 2018 | ProSun International, LLC ProSun Onyx 32 Sli Intensive (12 minutes) tanning bed, Model 32/1. Labeled as the following: PROSUN ONYX 32 SLI INTENSIVE RED, PROSUN ONYX 32 SLI INTENSIVE PEARL WHITE, ANYTIME FITNESS ONYX 32 SLI IN Terminated |
LEJ | K181455 |
| Dec 2, 2017 | ProSun International, LLC Sundream 12 V tanning bed Terminated |
LEJ | None listed |
| Sep 12, 2014 | JK Products & Services, Inc SUN DASH RADIUS 252 PN 8000809705.
The device is intended to be used for the tanning of human skin. Terminated |
LEJ | K932483 |
| Sep 7, 2012 | JK Products & Services, Inc SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation.
The device is intended to be used for tanning of the human skin. Terminated |
LEJ | None listed |
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