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FDA 510(k)

Exceed Microneedling Device

K-Number: K180778 · 2018-09-07

ApplicantMt. Derm GmbH
Decision Date2018-09-07
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Exceed Microneedling Device is the device name listed in this FDA 510(k) record. The listed applicant is Mt. Derm GmbH. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K180778. 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 Exceed Microneedling Device?

Exceed Microneedling Device is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Mt. Derm GmbH. The 510(k) number is K180778.

When did Exceed Microneedling Device receive FDA 510(k) clearance?

Exceed Microneedling Device received FDA 510(k) clearance on 2018-09-07, under 510(k) number K180778.

Who is the listed applicant for Exceed Microneedling Device?

The FDA 510(k) record lists Mt. Derm GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Exceed Microneedling Device?

The FDA product code for Exceed Microneedling Device is QAI.

Other records listing Mt. Derm GmbH 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.

K233709Exceed UnlimitedK182407Exceed Microneedling device

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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