FDA 510(k)

Exceed Microneedling Device

K-Number: K180778 · 2018-09-07

Decision Date2018-09-07

Product CodeQAI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Exceed Microneedling Device is a medical device manufactured by Mt. Derm GmbH. It received FDA 510(k) clearance on 2018-09-07 under approval 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. It is manufactured by Mt. Derm GmbH. The 510(k) number is K180778.

When was Exceed Microneedling Device approved by the FDA?

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

What company makes Exceed Microneedling Device?

Exceed Microneedling Device is manufactured by Mt. Derm GmbH.

What is the FDA product code for Exceed Microneedling Device?

The FDA product code for Exceed Microneedling Device is QAI.

Related Clinical Trials

NCT07533058 Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota During Orthodontic Treatment: A Split-Mouth Study. RECRUITING NCT06228144 Radio-Frequency Microneedling Device TERMINATED

Other Devices by Mt. Derm GmbH

K182407Exceed Microneedling device K233709Exceed Unlimited

Related Devices (Code: QAI)

DEN160029SkinPen Precision SystemBellus Medical, LLC K182407Exceed Microneedling deviceMt. Derm GmbH K200044SkinStylus SteriLock MicroSystemEsthetic Education, LLC K192138Rejuvapen NXTRefine USA, LLC K212558MicroPen EVOEclipse Medcorp, LLC K202517Cytrellis Dermal Micro-Coring SystemCytrellis Biosystems, Inc.

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.