FDA.reportPublic FDA data

Cosmetic micro-needling electronic handpiece, professional

Definition
A hand-held, electrically-powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, and/or hair loss; it is not intended for energy-based skin treatment. This is a reusable device.
GUDID devices
33
Last updated
2026-10-15 14:55:30

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
06976749540012Dr.PenGUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO.,LTD.A202024-08-06
08800118100355CODE-XWoorhi Mechatronics Co., Ltd.CODE-X2026-09-04
00810007534251SKINSTYLUS STERILOCK MICROSYSTEMHydrafacial LLCSKINSTYLUS STERILOCK MICROSYSTEM2026-03-27
EMTDE104902USMP0FootswitchMT.DERM GmbHE104902USMP2026-06-08
00850035498262SP MicroPen EVOBellus Medical, LLCF5SP2162022-05-25
080555980600681NEED ProCAMPOMATS SRLASCAMPOMATS_1NEED_MN_PRO2025-12-03
08800016000443E-PENBOMTECH ELECTRONICS CO., LTD.Powered Microneedle Device2026-04-29
B933ELSYS02R0ellacorCytrellis Biosystems, Inc.EL-SYS02-R2025-10-20
EMTD104802USMP0Footswitch MT.DERM GmbHE104802USMP 2024-01-10
EMTDAD64801USMP1ExceedMT.DERM GmbHAD64801USMP2024-01-10
EMTDAD64901USMP0Bio Touch PrecisionMT.DERM GmbHAD64901USMP2026-05-22
EMTDCF104901USMP0Bio Touch AeroMT.DERM GmbHCF104901USMP2026-05-22
EMTDCG100206USMP0Exceed UnlimitedMT.DERM GmbHCG100206USMP2026-05-22
00666151621305PRO Pen Microneedling SystemDermalogica, LLC68832026-01-31
B933ELKIT04ellacorCytrellis Biosystems, Inc.EL-KIT042025-12-16
080555980600511NEED ProCAMPOMATS SRLASCAMPOMATS_1NEED_MN_PRO2025-12-03
04260446131065XCELLARISPRO TWIST microneedling deviceDermaroller GmbHVK-3000.002.022025-08-26
04260446131089XCELLARISPRO TWIST HandpieceDermaroller GmbHVK-2000.011.012025-08-26
00850061586018NanoPen Zizion Group Inc.Pro 2024-12-26
B933ELKIT03ellacorCytrellis Biosystems, Inc.EL-KIT032024-11-01
00850060751004SkinPen Precision EliteBellus Medical, LLCREF2002024-10-01
00850060751011SkinPen Precision EliteBellus Medical, LLCREF2012024-10-01
00850060751035SkinPen Precision EliteBellus Medical, LLCREF200/REF2012024-10-01
B933ELKIT02ellacorCytrellis Biosystems, Inc.EL-KIT022024-05-29
07290016814415endyMed PRO MAX, Intensif MAX HandpieceENDYMED MEDICAL LTDIntensif MAX Handpiece2024-05-16
B933ELSYS02ellacorCytrellis Biosystems, Inc.EL-SYS022024-05-08
B933ELCON02R0EllacorCytrellis Biosystems, Inc.EL-CON02-R2024-01-31
B933ELHPC02EllacorCytrellis Biosystems, Inc.EL-HPC022024-01-31
B933ELHPC02R0EllacorCytrellis Biosystems, Inc.EL-HPC02-R2024-01-31
B933ELCON02ellacorCytrellis Biosystems, Inc.EL-CON022024-01-03
B933ELKIT010ellacorCytrellis Biosystems, Inc.EL-KIT012024-01-03
B933ELSYS01ellacorCytrellis Biosystems, Inc.EL-SYS012024-01-03
00196852554485SkinStylusEsthetic Medical IncMP1209SL12023-01-12