510(k) K161394

HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux by Sportarredo Group S.C. — Product Code LEJ

K161394 is an FDA 510(k) premarket notification submitted by Sportarredo Group S.C. for the device "HPO Exotic, LP1, LP2, LP3, Mastersun 360, Mastersun 360 New Reflector, Vega Lux". The FDA issued a decision of Substantially Equivalent on July 6, 2017. The device falls under product code LEJ (Booth, Sun Tan), a Class II device regulated under 21 CFR 878.4635. Sportarredo Group S.C. has at least 1 other 510(k) clearance on record.