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510(k) K203144

MicroPen EVO by Eclipse Medcorp, LLC — Product Code QAI

K203144 is an FDA 510(k) premarket notification submitted by Eclipse Medcorp, LLC for the device "MicroPen EVO". The FDA issued a decision of Substantially Equivalent on May 25, 2021. The device falls under product code QAI (Powered Microneedle Device), a Class II device regulated under 21 CFR 878.4430. Eclipse Medcorp, LLC has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2021
Date Received
October 21, 2020
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 by Eclipse Medcorp, LLC

  • K213690 — Eclipse Blood Collection Set (October 26, 2022)
  • K212558 — MicroPen EVO (November 24, 2021)
  • K200017 — Eclipse DermaFlex Cannula (November 5, 2020)

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)
  • 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)

FDA data resources