510(k) K240456

Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap by Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC — Product Code OAP

K240456 is an FDA 510(k) premarket notification submitted by Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC for the device "Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap". The FDA issued a decision of Substantially Equivalent on May 22, 2024. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500.