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FDA 510(k)

ellacor System with Micro-Coring Technology

K-Number: K252752 · 2025-10-30

ApplicantCytrellis Biosystems, Inc.
Decision Date2025-10-30
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ellacor System with Micro-Coring Technology is the device name listed in this FDA 510(k) record. The listed applicant is Cytrellis Biosystems, Inc.. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K252752. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ellacor System with Micro-Coring Technology?

ellacor System with Micro-Coring Technology is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is Cytrellis Biosystems, Inc.. The 510(k) number is K252752.

When did ellacor System with Micro-Coring Technology receive FDA 510(k) clearance?

ellacor System with Micro-Coring Technology received FDA 510(k) clearance on 2025-10-30, under 510(k) number K252752.

Who is the listed applicant for ellacor System with Micro-Coring Technology?

The FDA 510(k) record lists Cytrellis Biosystems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ellacor System with Micro-Coring Technology?

The FDA product code for ellacor System with Micro-Coring Technology is QAI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT03228641Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin LaxityCOMPLETED

Other records listing Cytrellis Biosystems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202517Cytrellis Dermal Micro-Coring System

Related Devices (Code: QAI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252591Automatic Micro Needle System (CODE-X)Woorhi Mechatronics Co., Ltd.K253002SkinStylus SteriLock MicroSystem (MP1209SL)Esthetic Medical, Inc.K253153SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLCK243800PRO Pen Microneedling System (6883)Dermalogica, LLCK243143E-PEN (E-PEN)Bomtech Electronics Co., Ltd.K2434721NEED ProCampomats S.R.L.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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