510(k) K191881

KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun by Kbl GmbH — Product Code LEJ

K191881 is an FDA 510(k) premarket notification submitted by Kbl GmbH for the device "KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun". The FDA issued a decision of Substantially Equivalent on October 28, 2019. The device falls under product code LEJ (Booth, Sun Tan), a Class II device regulated under 21 CFR 878.4635. Kbl GmbH has at least 1 other 510(k) clearance on record.