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SkinPen Precision Elite System

by Crown Aesthetics EUDAMED510(k)

Active European Union and United States

510(k) K241400

Overview

The SkinPen Precision Elite System is a powered microneedle device designed for controlled dermal treatment. It delivers precise, automated microneedling to the skin, facilitating procedures such as collagen induction, skin rejuvenation, and scar revision by creating microchannels for improved absorption of topical treatments or natural healing responses.

This device is intended for use in clinical settings by trained professionals, such as dermatologists or plastic surgeons, and is supplied as a reusable system with disposable microneedle cartridges. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance and MDR authorization. The system operates in non-MRI environments and requires proper sterilization and storage as per manufacturer guidelines.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK241400 Date29 Aug 2024ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
QAI
Device Class
Class II
Regulation
21 CFR Part 878.4430
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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Questions

  • What clinical procedures is the SkinPen Precision Elite System primarily used for in professional settings?

    The SkinPen Precision Elite System is designed for controlled dermal treatment procedures such as collagen induction, skin rejuvenation, and scar revision. It creates microchannels in the skin to enhance absorption of topical treatments or stimulate natural healing responses, making it suitable for dermatologists and plastic surgeons in clinical environments.

  • Is the SkinPen Precision Elite System reusable, and if so, how are the disposable components handled?

    Yes, the SkinPen Precision Elite System itself is reusable, but it requires the use of disposable microneedle cartridges for each procedure. This design ensures hygiene and reduces cross-contamination risks while maintaining the system’s functionality for multiple treatments.

  • What storage and sterilization guidelines should be followed for the SkinPen Precision Elite System?

    The SkinPen Precision Elite System must be sterilized and stored according to the manufacturer’s guidelines to ensure safety and efficacy. Since it is a reusable device, proper sterilization protocols are critical to prevent infection and maintain performance between uses.

  • Does the SkinPen Precision Elite System have any restrictions on its use in medical environments?

    Yes, the SkinPen Precision Elite System is intended for use in non-MRI environments. This means it should not be operated or stored in areas where magnetic resonance imaging is conducted, as the device may interfere with MRI equipment or safety protocols.