510(k) Report

Devices descending from DEN160029

25 later devices reach SkinPen Precision System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243143E-Pen (E-Pen)Bomtech Electronics Co., Ltd.20250—
+1K241790XCELLARISPRO TWIST microneedling deviceDermaroller GmbH20250—
+1K230420Dr. pen Microneedling SystemGuangzhou Ekai Electronic Technology Co., Ltd.20233—
+1K221070DP4 Microneedling deviceEquipmed USA, LLC20220—
+1K203144MicroPen EVOEclipse Medcorp, LLC20210—
+1K200044SkinStylus SteriLock MicroSystemEsthetic Education, LLC20202—
+1K192138Rejuvapen NXTRefine USA, LLC20200—
+1K182407Exceed Microneedling deviceMt. Derm GmbH20192—
+1K180778Exceed Microneedling DeviceMt. Derm GmbH201813—
+2K252591Automatic Micro Needle System (CODE-X)Woorhi Mechatronics Co., Ltd.20260—
+2K253002SkinStylus SteriLock MicroSystem (MP1209SL)Esthetic Medical, Inc.20260—
+2K243800PRO Pen Microneedling System (6883)Dermalogica, LLC20250—
+2K2434721NEED ProCampomats S.R.L.20250—
+2K241355SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC20241—
+2K233709Exceed UnlimitedMt. Derm GmbH20240—
+2K202517Cytrellis Dermal Micro-Coring SystemCytrellis Biosystems, Inc.202122
+2K202243SkinPen Precision SystemCrown Aesthetics20217—
+3K252752ellacor System with Micro-Coring TechnologyCytrellis Biosystems, Inc.20250—
+3K253153SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC20250—
+3K221011AI.ME SystemVenus Concept USA, Inc.20220—
+3K220506SkinPen Precision SystemCrown Aesthetics20225—
+3K212558MicroPen EVOEclipse Medcorp, LLC20210—
+4K241400SkinPen Precision Elite SystemCrown Aesthetics20240—
+4K222199Collagen P.I.N. (Percutaneous Induction Needling)Induction Therapies, LLC20223—
+5K231073SkinStylus SteriLock® MicroSystem, Model Number MP1209SLEsthetic Medical, Inc.20230—