Cleared Traditional

K252752 - ellacor System with Micro-Coring Technology (FDA 510(k) Clearance)

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

K252752 · Cytrellis Biosystems, Inc. · General & Plastic Surgery device
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Oct 2025
Decision
62d
Days
Class 2
Risk

K252752 is an FDA 510(k) clearance for the ellacor System with Micro-Coring Technology. 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 October 30, 2025 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cytrellis Biosystems, Inc. devices

Submission Details

510(k) Number K252752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2025
Decision Date October 30, 2025
Days to Decision 62 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
52d faster than avg
Panel avg: 114d · This submission: 62d
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 24
Devices cleared under the same product code (QAI) and FDA review panel - the closest regulatory comparables to K252752.
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