Home / 510(k) Clearances / K241400

510(k) K241400

SkinPen Precision Elite System by Crown Aesthetics — Product Code QAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2024
Date Received
May 17, 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 by Crown Aesthetics

  • K220506 — SkinPen Precision System (March 7, 2022)
  • K202243 — SkinPen Precision System (April 2, 2021)

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)
  • K233709 — Exceed Unlimited (February 23, 2024)
  • K230420 — Dr. pen Microneedling System (August 11, 2023)