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510(k) K253153

SER Pen Carain MicroSystem (MP1209SP) by Su-Ko Technologies, LLC — Product Code QAI

K253153 is an FDA 510(k) premarket notification submitted by Su-Ko Technologies, LLC for the device "SER Pen Carain MicroSystem (MP1209SP)". The FDA issued a decision of Substantially Equivalent on October 29, 2025. The device falls under product code QAI (Powered Microneedle Device), a Class II device regulated under 21 CFR 878.4430. Su-Ko Technologies, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2025
Date Received
September 26, 2025
Clearance Type
Special
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 by Su-Ko Technologies, LLC

  • K241355 — SER Pen Carain MicroSystem (MP1209SP) (October 9, 2024)

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)
  • K243800 — PRO Pen Microneedling System (6883) (August 25, 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