Cleared Special

SkinPen Precision System (K220506) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K220506 · Crown Aesthetics · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
13d
Days
Class 2
Risk

K220506 is an FDA 510(k) clearance for the SkinPen Precision System. Classified as Powered Microneedle Device (product code QAI), Class II - Special Controls.

Submitted by Crown Aesthetics (Dallas, US). The FDA issued a Cleared decision on March 7, 2022 after a review of 13 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4430 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Crown Aesthetics devices

Submission Details

510(k) Number K220506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2022
Decision Date March 07, 2022
Days to Decision 13 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QAI Powered Microneedle Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4430
Definition A Powered Microneedle Device Is A Device Using One Or More Needles To Mechanically Puncture And Injure Skin Tissue For Aesthetic Use.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - QAI Powered Microneedle Device

All 25
Devices cleared under the same product code (QAI) and FDA review panel - the closest regulatory comparables to K220506.
AI.ME System
K221011 · Venus Concept USA, Inc. · Dec 2022
DP4 Microneedling device
K221070 · Equipmed USA, LLC · Dec 2022
Collagen P.I.N. (Percutaneous Induction Needling)
K222199 · Induction Therapies, LLC · Oct 2022
MicroPen EVO
K212558 · Eclipse Medcorp, LLC · Nov 2021
Cytrellis Dermal Micro-Coring System
K202517 · Cytrellis Biosystems, Inc. · Jul 2021
MicroPen EVO
K203144 · Eclipse Medcorp, LLC · May 2021