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510(k) K241790

XCELLARISPRO TWIST microneedling device by Dermaroller GmbH — Product Code QAI

K241790 is an FDA 510(k) premarket notification submitted by Dermaroller GmbH for the device "XCELLARISPRO TWIST microneedling device". The FDA issued a decision of Substantially Equivalent on March 6, 2025. The device falls under product code QAI (Powered Microneedle Device), a Class II device regulated under 21 CFR 878.4430.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2025
Date Received
June 21, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powered Microneedle Device
Device Class
Class II
Regulation Number
878.4430
Review Panel
SU
Submission Type

A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.

Other clearances for product code QAI

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  • K253002 — SkinStylus SteriLock MicroSystem (MP1209SL) (February 19, 2026)
  • K252752 — ellacor System with Micro-Coring Technology (October 30, 2025)
  • K253153 — SER Pen Carain MicroSystem (MP1209SP) (October 29, 2025)
  • K243800 — PRO Pen Microneedling System (6883) (August 25, 2025)
  • K243143 — E-PEN (E-PEN) (April 7, 2025)
  • K243472 — 1NEED Pro (March 19, 2025)
  • K241355 — SER Pen Carain MicroSystem (MP1209SP) (October 9, 2024)
  • K241400 — SkinPen Precision Elite System (August 29, 2024)
  • K233709 — Exceed Unlimited (February 23, 2024)

FDA data resources