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FDA 510(k)

PRO Pen Microneedling System (6883)

K-Number: K243800 · 2025-08-25

ApplicantDermalogica, LLC
Decision Date2025-08-25
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PRO Pen Microneedling System (6883) is the device name listed in this FDA 510(k) record. The listed applicant is Dermalogica, LLC. It received FDA 510(k) clearance on 2025-08-25 under 510(k) number K243800. 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 PRO Pen Microneedling System (6883)?

PRO Pen Microneedling System (6883) is a medical device that received FDA 510(k) clearance on 2025-08-25. The listed applicant is Dermalogica, LLC. The 510(k) number is K243800.

When did PRO Pen Microneedling System (6883) receive FDA 510(k) clearance?

PRO Pen Microneedling System (6883) received FDA 510(k) clearance on 2025-08-25, under 510(k) number K243800.

Who is the listed applicant for PRO Pen Microneedling System (6883)?

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

What is the FDA product code for PRO Pen Microneedling System (6883)?

The FDA product code for PRO Pen Microneedling System (6883) is QAI.

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, 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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