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510(k) K202243

SkinPen Precision System by Crown Aesthetics — Product Code QAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2021
Date Received
August 10, 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 Crown Aesthetics

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  • K220506 — SkinPen Precision System (March 7, 2022)

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  • 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)