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FDA 510(k)

Rejuvapen NXT

K-Number: K192138 · 2020-04-09

ApplicantRefine USA, LLC
Decision Date2020-04-09
Product CodeQAI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Rejuvapen NXT is the device name listed in this FDA 510(k) record. The listed applicant is Refine USA, LLC. It received FDA 510(k) clearance on 2020-04-09 under 510(k) number K192138. 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 Rejuvapen NXT?

Rejuvapen NXT is a medical device that received FDA 510(k) clearance on 2020-04-09. The listed applicant is Refine USA, LLC. The 510(k) number is K192138.

When did Rejuvapen NXT receive FDA 510(k) clearance?

Rejuvapen NXT received FDA 510(k) clearance on 2020-04-09, under 510(k) number K192138.

Who is the listed applicant for Rejuvapen NXT?

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

What is the FDA product code for Rejuvapen NXT?

The FDA product code for Rejuvapen NXT 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.

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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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