Cleared Traditional

K253002 - SkinStylus SteriLock MicroSystem (MP1209SL) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K253002 · Esthetic Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
153d
Days
Class 2
Risk

K253002 is an FDA 510(k) clearance for the SkinStylus SteriLock MicroSystem (MP1209SL). Classified as Powered Microneedle Device (product code QAI), Class II - Special Controls.

Submitted by Esthetic Medical, Inc. (Long Beach, US). The FDA issued a Cleared decision on February 19, 2026 after a review of 153 days - an extended review 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. 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 K253002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2025
Decision Date February 19, 2026
Days to Decision 153 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
39d slower than avg
Panel avg: 114d · This submission: 153d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06032286 Completed Interventional Industry-sponsored

Evaluation of Efficacy and Safety of the Skinstylus Sterilock Microneedling System for the Treatment of Facial Wrinkles

51
Patients (actual)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Subjects Displaying Facial Ageing
Study design Single group
Eligibility All sexes · 35 Years+ · Healthy volunteers accepted
Sponsor Beauty Health (industry)
Started 2023-09-08 → Primary completion 2024-05-09
Primary outcome
Wrinkle improvement
Secondary outcome
Texture and laxity
Study completed - no results published. This trial concluded in 2024 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - QAI Powered Microneedle Device

All 24
Devices cleared under the same product code (QAI) and FDA review panel - the closest regulatory comparables to K253002.
ellacor System with Micro-Coring Technology
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SER Pen Carain MicroSystem (MP1209SP)
K253153 · Su-Ko Technologies, LLC · Oct 2025
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E-PEN (E-PEN)
K243143 · Bomtech Electronics Co., Ltd. · Apr 2025
1NEED Pro
K243472 · Campomats S.R.L. · Mar 2025
XCELLARISPRO TWIST microneedling device
K241790 · Dermaroller GmbH · Mar 2025