Powered Microneedle Device
FDA product code QAI · 25 cleared devices
Class 2
General, Plastic Surgery
- Regulation
- 21 CFR 878.4430
- Review panel
- SU
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 2018-09-07 – 2026-05-13
A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.
QAI
2026-05-13
QAI
2026-02-19
SkinStylus SteriLock MicroSystem (MP1209SL)
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QAI
2025-10-30
ellacor System with Micro-Coring Technology
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QAI
2025-10-29
SER Pen Carain MicroSystem (MP1209SP)
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QAI
2025-08-25
PRO Pen Microneedling System (6883)
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QAI
2025-04-07
E-PEN (E-PEN)
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QAI
2025-03-19
1NEED Pro
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QAI
2025-03-06
XCELLARISPRO TWIST microneedling device
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QAI
2024-10-09
SER Pen Carain MicroSystem (MP1209SP)
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QAI
2024-08-29
SkinPen Precision Elite System
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QAI
2024-02-23
Exceed Unlimited
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QAI
2023-08-11
Dr. pen Microneedling System
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QAI
2023-07-28
SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
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QAI
2022-12-20
DP4 Microneedling device
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QAI
2022-12-20
AI.ME System
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QAI
2022-10-21
Collagen P.I.N. (Percutaneous Induction Needling)
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QAI
2022-03-07
SkinPen Precision System
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QAI
2021-11-24
MicroPen EVO
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QAI
2021-07-09
Cytrellis Dermal Micro-Coring System
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QAI
2021-05-25
MicroPen EVO
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QAI
2021-04-02
SkinPen Precision System
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QAI
2020-04-10
SkinStylus SteriLock MicroSystem
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QAI
2020-04-09
Rejuvapen NXT
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QAI
2019-07-19
Exceed Microneedling device
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QAI
2018-09-07
Exceed Microneedling Device
View details →No matching devices.
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