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510(k) K252752

ellacor System with Micro-Coring Technology by Cytrellis Biosystems, Inc. — Product Code QAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2025
Date Received
August 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powered Microneedle Device
Device Class
Class II
Regulation Number
878.4430
Review Panel
SU
Submission Type

A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.

Other clearances by Cytrellis Biosystems, Inc.

  • K202517 — Cytrellis Dermal Micro-Coring System (July 9, 2021)

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  • K241790 — XCELLARISPRO TWIST microneedling device (March 6, 2025)
  • K241355 — SER Pen Carain MicroSystem (MP1209SP) (October 9, 2024)
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  • K230420 — Dr. pen Microneedling System (August 11, 2023)