510(k) Report

Devices descending from K192545

20 later devices reach Potenza through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+1K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+1K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+1K203728DarwinLuvo Medical Technologies, Inc.20211—
+1K201685PotenzaJeisys Medical, Inc.20219—
+1K201735PlaDuo SystemShenB Co., Ltd.20203—
+2K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+2K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+2K242688Finiff SystemSkingrab Co., Ltd.20240—
+2K231216PotenzaJeisys Medical, Inc.20244—
+2K231287PotenzaJeisys Medical, Inc.20241—
+2K230837PlazMagikAgnes Medical Co., Ltd.20240—
+2K232223PlaDuo SystemShenB Co., Ltd.20230—
+2K212472AgeJetTriworks Group Srl20220—
+2K212607DarwinLuvo Medical Technologies, Inc.20210—
+3K254185Potenza PrimeJeisys Medical Incorporated20260—
+3K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+3K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+4K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+4K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—