Cleared Traditional

Cytrellis Dermal Micro-Coring System (K202517) - FDA 510(k) Clearance

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

K202517 · Cytrellis Biosystems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
311d
Days
Class 2
Risk

K202517 is an FDA 510(k) clearance for the Cytrellis Dermal Micro-Coring System. Classified as Powered Microneedle Device (product code QAI), Class II - Special Controls.

Submitted by Cytrellis Biosystems, Inc. (Woburn, US). The FDA issued a Cleared decision on July 9, 2021 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cytrellis Biosystems, Inc. devices

Submission Details

510(k) Number K202517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2020
Decision Date July 09, 2021
Days to Decision 311 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
196d slower than avg
Panel avg: 115d · This submission: 311d
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 K202517.
Collagen P.I.N. (Percutaneous Induction Needling)
K222199 · Induction Therapies, LLC · Oct 2022
SkinPen Precision System
K220506 · Crown Aesthetics · Mar 2022
MicroPen EVO
K212558 · Eclipse Medcorp, LLC · Nov 2021
MicroPen EVO
K203144 · Eclipse Medcorp, LLC · May 2021
SkinPen Precision System
K202243 · Crown Aesthetics · Apr 2021
SkinStylus SteriLock MicroSystem
K200044 · Esthetic Education, LLC · Apr 2020