510(k) Report

Devices descending from K153727

27 later devices reach INTRAcel Premium Fractional RF Micro Needle (FRM) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192545PotenzaJeisys Medical Incorporated202020—
+1K183284INTRAcel RF Microneedle SystemJeisys Medical, Inc.20200—
+1K160469AGNESGowoonsesang Cosmetics Co., Ltd.20179—
+2K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+2K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+2K232301Define RF Microneedling SystemAesthetic Management Partners20240—
+2K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+2K203728DarwinLuvo Medical Technologies, Inc.20211—
+2K201685PotenzaJeisys Medical, Inc.20219—
+2K201735PlaDuo SystemShenB Co., Ltd.20203—
+2K192728AgnesAgnes Medical Co., Ltd.20196—
+3K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+3K243176BLESSING SystemCellah Medical Co., Ltd.20251—
+3K242688Finiff SystemSkingrab Co., Ltd.20240—
+3K231216PotenzaJeisys Medical, Inc.20244—
+3K231287PotenzaJeisys Medical, Inc.20241—
+3K230837PlazMagikAgnes Medical Co., Ltd.20240—
+3K232223PlaDuo SystemShenB Co., Ltd.20230—
+3K203013AGNESAgnes Medical Co., Ltd.20224—
+3K212472AgeJetTriworks Group Srl20220—
+3K212607DarwinLuvo Medical Technologies, Inc.20210—
+4K254185Potenza PrimeJeisys Medical Incorporated20260—
+4K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+4K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+4K223805AgnesAgnes Medical Co., Ltd.20233—
+5K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+5K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—