Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Refine USA, LLC. It received FDA 510(k) clearance on 2020-04-09 under approval 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. It is manufactured by Refine USA, LLC. The 510(k) number is K192138.

When was Rejuvapen NXT approved by the FDA?

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

What company makes Rejuvapen NXT?

Rejuvapen NXT is manufactured by Refine USA, LLC.

What is the FDA product code for Rejuvapen NXT?

The FDA product code for Rejuvapen NXT is QAI.

Related Devices (Code: QAI)

K180778Exceed Microneedling DeviceMt. Derm GmbH DEN160029SkinPen Precision SystemBellus Medical, LLC K182407Exceed Microneedling deviceMt. Derm GmbH K200044SkinStylus SteriLock MicroSystemEsthetic Education, LLC K212558MicroPen EVOEclipse Medcorp, LLC K202517Cytrellis Dermal Micro-Coring SystemCytrellis Biosystems, Inc.

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.

↑