FDA.reportPublic FDA data

510(k) K252752

Device
ellacor System with Micro-Coring Technology
Applicant
Cytrellis Biosystems, Inc.
510(k) number
K252752
Product code
QAI
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-30
Date received
2025-08-29
Regulation
878.4430
Classification name
Powered Microneedle Device
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Robert Hinz
Address
34 Commerce Way Woburn MA US 01801 01801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QAI#

510(k), Device, Applicant table
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K241790XCELLARISPRO TWIST microneedling deviceDermaroller GmbH2025-03-06
K241355SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLC2024-10-09
K233709Exceed UnlimitedMt. Derm GmbH2024-02-23
K230420Dr. pen Microneedling SystemGuangzhou Ekai Electronic Technology Co., Ltd.2023-08-11
K231073SkinStylus SteriLock® MicroSystem, Model Number MP1209SLEsthetic Medical, Inc.2023-07-28
K221011AI.ME SystemVenus Concept USA, Inc.2022-12-20
K221070DP4 Microneedling deviceEquipmed USA, LLC2022-12-20
K222199Collagen P.I.N. (Percutaneous Induction Needling)Induction Therapies, LLC2022-10-21
K220506SkinPen Precision SystemCrown Aesthetics2022-03-07