Cleared Traditional

SkinStylus SteriLock® MicroSystem, Model Number MP1209SL (K231073) - FDA 510(k) Clearance

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

K231073 · Esthetic Medical, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2023
Decision
105d
Days
Class 2
Risk

K231073 is an FDA 510(k) clearance for the SkinStylus SteriLock® MicroSystem, Model Number MP1209SL. Classified as Powered Microneedle Device (product code QAI), Class II - Special Controls.

Submitted by Esthetic Medical, Inc. (Scottsdale, US). The FDA issued a Cleared decision on July 28, 2023 after a review of 105 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 Esthetic Medical, Inc. devices

Submission Details

510(k) Number K231073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2023
Decision Date July 28, 2023
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
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 Consultant

Contract In-House Counsel and Consultants,
Marc C Sanchez

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K231073.
SkinPen Precision Elite System
K241400 · Crown Aesthetics · Aug 2024
Exceed Unlimited
K233709 · Mt. Derm GmbH · Feb 2024
Dr. pen Microneedling System
K230420 · Guangzhou Ekai Electronic Technology Co., Ltd. · Aug 2023
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