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FDA 510(k)

Cytrellis Dermal Micro-Coring System

K-Number: K202517 · 2021-07-09

ApplicantCytrellis Biosystems, Inc.
Decision Date2021-07-09
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cytrellis Dermal Micro-Coring System 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 2021-07-09 under 510(k) number K202517. 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 Cytrellis Dermal Micro-Coring System?

Cytrellis Dermal Micro-Coring System is a medical device that received FDA 510(k) clearance on 2021-07-09. The listed applicant is Cytrellis Biosystems, Inc.. The 510(k) number is K202517.

When did Cytrellis Dermal Micro-Coring System receive FDA 510(k) clearance?

Cytrellis Dermal Micro-Coring System received FDA 510(k) clearance on 2021-07-09, under 510(k) number K202517.

Who is the listed applicant for Cytrellis Dermal Micro-Coring System?

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 Cytrellis Dermal Micro-Coring System?

The FDA product code for Cytrellis Dermal Micro-Coring System is QAI.

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.

K252752ellacor System with Micro-Coring Technology

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.K252752ellacor System with Micro-Coring TechnologyCytrellis Biosystems, Inc.K253153SER Pen Carain MicroSystem (MP1209SP)Su-Ko Technologies, LLCK243800PRO Pen Microneedling System (6883)Dermalogica, LLCK243143E-PEN (E-PEN)Bomtech Electronics Co., Ltd.

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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