Powered Microneedle Device
General, Plastic Surgery · 21 CFR 878.4430
A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.
Recent MDR events
59 adverse event reports on file
- MICRONEEDLINGJul 16, 2026InjuryUnkMW5190747
- SKINPEN PRECISION ELITE SYSTEM (POWERED MICRONEEDLE DEVICE)Jul 1, 2026Injury3010392991-2026-00004
- SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE)Mar 6, 2026Injury3010392991-2026-00003
- SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE)Feb 19, 2026Injury3010392991-2026-00002
- MICROPEN EVO MICRONEEDLING DEVICEJan 9, 2026Injury3010392991-2026-00001
- SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE)Dec 22, 2025Injury3010392991-2025-00005
- SKINPEN PRECISION ELITE SYSTEM (POWERED MICRONEEDLE DEVICE)Nov 24, 2025Injury3010392991-2025-00004
- RADIOLOGIST FREQUENCY MICRONEEDLERNov 7, 2025InjuryUnknownMW5178679
- SKINPEN PRECISION SYSTEM (POWERED MICRONEEDLE DEVICE)Oct 30, 2025Injury3010392991-2025-00003
- RF MICRONEEDLEOct 28, 2025InjuryUnknownMW5178170
Event type breakdown
Recalls
3 recall events for this product code
- Cytrellis Biosystems, Inc.Open, ClassifiedAug 11, 2023
ellacor System with Micro-Coring Technology-Indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower fa
Potential failure of a bearing adhesive joint that can occur due to an assembly issue of the X/Y stage of the handpiece. If a broken glue bond were to occur, it could cause an overlap of cores, potentially leading to prolonged healing and irregularities in patient skin texture post-treatment, and/or scarring
Z-2393-2023 · View FDA record ↗ - Cytrellis Biosystems, Inc.CompletedMay 26, 2023
Cytrellis ellacor System with Micro-Coring Technology-Dermal Micro-Coring System System intended for the treatment of moderate and severe wrinkles in the mid an
Irregular core patterns could cause potential overlap of cores at the 8% setting, potentially leading to prolonged healing, irregularities in patient skin texture post-treatment, and/or scarring.
Z-1648-2023 · View FDA record ↗ - Bellus MedicalTerminatedUnknown
SKINFUSE Resuce Calming Complex Kit containing:
Cosmetic Kit was packaged with a mislabel medical product.
Z-0660-2020 · View FDA record ↗
Registered firms
78 firms currently registered for this product code
Syrma Johari Medtech Limited
Jodhpur Rajasthan, IN
Plandocs Usa, Inc.
Orange, CA, US
Beijing Winkonlaser Technology Limited
Beijing, CN
Equipmed Usa Llc
Newport Beach, CA, US
Life Prp
Dallas, TX, US
Pan-international Precision Electronic Co., Ltd.
Dongguan Guangdong, CN
Woorhi Mechatronics
Gunpo-si Gyeonggi, KR
Su-ko Technologies Llc
Austin, TX, US
Nextphase Medical Devices Mexico Llc
TIJUANA Baja California, MX
Global Interconnect, Inc.
Pocasset, MA, US
Crown Laboratories, Inc.
Johnson City, TN, US
Hydrafacial Llc
Long Beach, CA, US
Trident Manufacturing, Inc.
Pingree Grove, IL, US
Midwest Sterilization Corp.
JACKSON, MO, US
Guangdong Carain Beauty Equipment Co., Ltd
Foshan Guangdong, CN
Dermaqual
Johnson City, TN, US
Mt.derm Medical Products Private Limited
Chengalpattu Tamil Nadu, IN
Bellus Medical, Llc
Johnson City, TN, US
Command Medical Nicaragua Sa
Managua, NI
Dermalogica, Llc
Carson, CA, US
Beijing Perfectlaser Technology Co.,ltd
Beijing, CN
J. Sterling Industries Ltd.
Woodbridge Ontario, CA
510(k) clearances
26 clearances for this product code
- Woorhi Mechatronics Co., Ltd.May 13, 2026
K252591 · Automatic Micro Needle System (CODE-X)
- Esthetic Medical, Inc.Feb 19, 2026
K253002 · SkinStylus SteriLock MicroSystem (MP1209SL)
- Cytrellis Biosystems, Inc.Oct 30, 2025
K252752 · ellacor System with Micro-Coring Technology
- Su-Ko Technologies, LLCOct 29, 2025
K253153 · SER Pen Carain MicroSystem (MP1209SP)
- Dermalogica, LLCAug 25, 2025
K243800 · PRO Pen Microneedling System (6883)
- Bomtech Electronics Co., Ltd.Apr 7, 2025
K243143 · E-PEN (E-PEN)
- Campomats S.R.L.Mar 19, 2025
K243472 · 1NEED Pro
- Dermaroller GmbHMar 6, 2025
K241790 · XCELLARISPRO TWIST microneedling device