FDA-Device2019-04-24Class II
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 INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin
ProSun International, LLC
Hazard
ProSun International LLC discovered discrepancies in their Quality Control Checklist documentation, which could result in high UV output.
Sold states
US Nationwide distribution to states of: CA, CO, FL, GA, IL, KY, LA, ME, MI, NC, NJ, NY, OH, OR, TN, TX, and WI.
Affected count
177 devices of which 31 are affected
Manufactured in
2442 23rd St N, N/A, Saint Petersburg, FL, United States
Products
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 INTENSIVE BRONZE, PROSUN ONYX 32 SLI INTENSIVE BRONZE Tanning of the skin
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1176-2019Don't want to check this manually?
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