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510(k) K243800

PRO Pen Microneedling System (6883) by Dermalogica, LLC — Product Code QAI

K243800 is an FDA 510(k) premarket notification submitted by Dermalogica, LLC for the device "PRO Pen Microneedling System (6883)". The FDA issued a decision of Substantially Equivalent on August 25, 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
August 25, 2025
Date Received
December 11, 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

  • K252591 — Automatic Micro Needle System (CODE-X) (May 13, 2026)
  • 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)
  • K243143 — E-PEN (E-PEN) (April 7, 2025)
  • K243472 — 1NEED Pro (March 19, 2025)
  • K241790 — XCELLARISPRO TWIST microneedling device (March 6, 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