510(k) K181455 ยท LEJ Booth, Sun Tan
ProSun sunlamp products, Luxura sunlamp products
| Applicant | Prosun International, LLC, Saint Petersburg FL, US |
| Decision | Substantially Equivalent, Sep 10, 2018 |
| Received | Jun 4, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181455
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.