K200044 is an FDA 510(k) clearance for the SkinStylus SteriLock MicroSystem. Classified as Powered Microneedle Device (product code QAI), Class II - Special Controls.
Submitted by Esthetic Education, LLC (Scottsdale, US). The FDA issued a Cleared decision on April 10, 2020 after a review of 93 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 Education, LLC devices
NCT03366194
Completed
Interventional
Industry-sponsored
The Clinical Efficacy And Safety Of SkinStylus Microneedling System
The Clinical Efficacy And Safety Of SkinStylus Microneedling System for Ventral Torso Hypertrophic Scars: Clinical Results With 30 Patients
| Condition studied |
Cicatrix, Hypertrophic |
| Study design |
Single group |
| Eligibility |
All sexes
· 23 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Toni Stockton, MD |
| Sponsor |
Esthetic Education LLC
(industry)
|
Started 2017-11-15
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Primary completion 2018-11-01
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Completed 2018-12-01
Primary outcome
Number of Participants With Improvement Assessed Using the VAS Scar Scoring System
Secondary outcome
Number of Patients Self-Reporting Improvement Using the Validated Self-Assessed Scar Improvement Scale Satisfaction Survey
View full study on ClinicalTrials.gov