Cleared Traditional

SkinPen Precision Elite System (K241400) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241400 · Crown Aesthetics · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
104d
Days
Class 2
Risk

K241400 is an FDA 510(k) clearance for the SkinPen Precision Elite 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 August 29, 2024 after a review of 104 days - within the typical 510(k) review window.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Crown Aesthetics devices

Submission Details

510(k) Number K241400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2024
Decision Date August 29, 2024
Days to Decision 104 days
Submission Type Traditional
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
11d faster than avg
Panel avg: 115d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K241400.
1NEED Pro
K243472 · Campomats S.R.L. · Mar 2025
XCELLARISPRO TWIST microneedling device
K241790 · Dermaroller GmbH · Mar 2025
SER Pen Carain MicroSystem (MP1209SP)
K241355 · Su-Ko Technologies, LLC · Oct 2024
Exceed Unlimited
K233709 · Mt. Derm GmbH · Feb 2024
Dr. pen Microneedling System
K230420 · Guangzhou Ekai Electronic Technology Co., Ltd. · Aug 2023
SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
K231073 · Esthetic Medical, Inc. · Jul 2023