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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Microneedle Device
510(k) Number K252752
Device Name ellacor System with Micro-Coring Technology
Applicant
Cytrellis Biosystems, Inc.
34 Commerce Way
Woburn,  MA  01801
Applicant Contact Robert Hinz
Correspondent
Cytrellis Biosystems, Inc.
34 Commerce Way
Woburn,  MA  01801
Correspondent Contact Robert Hinz
Regulation Number878.4430
Classification Product Code
QAI  
Date Received08/29/2025
Decision Date 10/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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