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510(k) K212558

MicroPen EVO by Eclipse Medcorp, LLC — Product Code QAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 24, 2021
Date Received
August 13, 2021
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)
  • K203144 — MicroPen EVO (May 25, 2021)
  • K200017 — Eclipse DermaFlex Cannula (November 5, 2020)

Other clearances for product code QAI

  • 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)
  • K233709 — Exceed Unlimited (February 23, 2024)