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FDA 510(k) & PMA Approved Devices — 4 products

Total Devices4
Categories3
Latest FDA decision2025-05-06
TypeNumberDevice NameCodeDateActions
510(k) K250253 IPL Hair Removal Device (KCA511/KCA516/KCA522)OHT2025-05-06 View
510(k) K250308 Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)OAP2025-04-29 View
510(k) K241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)OHS2024-10-11 View
510(k) K240282 IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521)OHT2024-04-03 View