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FDA 510(k)

DP4 Microneedling device

K-Number: K221070 · 2022-12-20

ApplicantEquipmed USA, LLC
Decision Date2022-12-20
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DP4 Microneedling device is the device name listed in this FDA 510(k) record. The listed applicant is Equipmed USA, LLC. It received FDA 510(k) clearance on 2022-12-20 under 510(k) number K221070. 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 DP4 Microneedling device?

DP4 Microneedling device is a medical device that received FDA 510(k) clearance on 2022-12-20. The listed applicant is Equipmed USA, LLC. The 510(k) number is K221070.

When did DP4 Microneedling device receive FDA 510(k) clearance?

DP4 Microneedling device received FDA 510(k) clearance on 2022-12-20, under 510(k) number K221070.

Who is the listed applicant for DP4 Microneedling device?

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

What is the FDA product code for DP4 Microneedling device?

The FDA product code for DP4 Microneedling device 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, LLCK243800PRO Pen Microneedling System (6883)Dermalogica, LLCK243143E-PEN (E-PEN)Bomtech Electronics Co., Ltd.

Official Source

View on FDA Database →

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

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